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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge
This study is an adaptive, prospective, randomized platform trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or matching placebo for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, 90 days).
The primary objective is to determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital.
Biobanking of samples for future biomarker and mechanistic studies will be available for centers able to participate and collect samples from eligible participants. Samples will be collected at the time of enrollment and after the completion of 30 days of therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Active Comparator | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
| Placebo | Placebo Comparator | Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 2.5 MG | Drug | Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. | Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30. | 30 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score. | Composite endpoint of mortality and EQ5D index at Day 30. All mortality events will be considered worse than any possible EQ5D response [QOL&M30]. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With All-cause Mortality | 30 days following discharge from hospital | |
| The Incidence of All-cause Rehospitalization for up to 90 Days After Randomization | 90 days following discharge from hospital |
Inclusion Criteria:
• Age ≥ 18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Wang, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valleywise Health Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Dignity Health-St Josephs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37591523 | Derived | Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2. | |
| 36940444 | Derived | Wang TY, Wahed AS, Morris A, Kreuziger LB, Quigley JG, Lamas GA, Weissman AJ, Lopez-Sendon J, Knudson MM, Siegal DM, Kasthuri RS, Alexander AJ, Wahid L, Atassi B, Miller PJ, Lawson JW, Patel B, Krishnan JA, Shapiro NL, Martin DE, Kindzelski AL, Leifer ES, Joo J, Lyu L, Pennella A, Everett BM, Geraci MW, Anstrom KJ, Ortel TL; ACTIV-4C Study Group. Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization. Ann Intern Med. 2023 Apr;176(4):515-523. doi: 10.7326/M22-3350. Epub 2023 Mar 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2022 | Mar 6, 2023 |
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Double Blind
|
|
| Placebo | Drug | Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
| 30 days after hospital discharge |
| The Composite Outcome of All-cause Mortality and the EQ5D Index Score. | Composite endpoint of mortality and EQ5D index at Day 90. All mortality events will be considered worse than any possible EQ5D response. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility. | 90 days after hospital discharge |
| The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. | 45 days after hospital discharge |
| The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. | 90 days after hospital discharge |
| New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records. | 30 days after randomization (which occurred at time of hospital discharge) |
| New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records. | 30 days after randomization (which occurred at time of hospital discharge) |
| The Individual Domains of EQ5D and the EQ5D Visual Analog Scale for 30 and 90 Days After Randomization | 30 and 90 days following discharge from hospital |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Central Arkansas Veterans Health Care System | Little Rock | Arkansas | 72205 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
| UCSF at Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | United States |
| New Ananda Medical and Urgent Care, Inc. | South El Monte | California | 91733 | United States |
| Mazur and Statner MD PC | Thousand Oaks | California | 91360 | United States |
| Torrance Medical Center | Torrance | California | 90502 | United States |
| Centura Health Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | United States |
| St. Anthony North Health Campus | Westminster | Colorado | 80023 | United States |
| Baycare Hospital | Clearwater | Florida | 33756 | United States |
| Florida Heart Center | Ft. Pierce | Florida | 34590 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Tallahassee Memorial HealthCare | Tallahassee | Florida | 32308 | United States |
| James A. Haley Veteran's Hospital | Tampa | Florida | 33612 | United States |
| BayCare Hospital- Winter Haven | Winter Haven | Florida | 33881 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| Medical College of Georgia/Augusta University | Augusta | Georgia | 30912 | United States |
| Savannah Health Services, LLC DBA Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Queens Medical Center | Honolulu | Hawaii | 96813 | United States |
| Hawaii Pacific Health | Honolulu | Hawaii | 96827 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60607 | United States |
| Cook County Health | Chicago | Illinois | 60612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| OSF Little Company of Mary | Evergreen Park | Illinois | 60805 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University Health Bloomington Hospital | Bloomington | Indiana | 47403 | United States |
| Lutheran Medical Group | Fort Wayne | Indiana | 46804 | United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Franciscan Health Michigan City | Michigan City | Indiana | 46360 | United States |
| Reid Physician Associates | Richmond | Indiana | 47374 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Ochsner Clinic Foundation-Baton Rouge | New Orleans | Louisiana | 70121 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Willis-Knighton Physician Network/Tri-State Medical Clinic | Shreveport | Louisiana | 71103 | United States |
| Maine Medical Center/Maine Medical Partners Adult Hospital Medicine | Portland | Maine | 04102 | United States |
| Pen Bay Medical Center | Rockport | Maine | 04856 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Lifebridge (Sinai Hospital of Baltimore) | Baltimore | Maryland | 21215 | United States |
| Adventist HealthCare Shady Grove Medical Center | Rockville | Maryland | 20850 | United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Baystate Medical center | Springfield | Massachusetts | 01199 | United States |
| Bay Regional Medical Center d/b/a/ McLaren Bay Region | Bay City | Michigan | 48708 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Western Michigan University | Kalamazoo | Michigan | 49008 | United States |
| MidMichigan Medical Center | Midland | Michigan | 48670 | United States |
| McLaren Macomb | Mount Clemens | Michigan | 48043 | United States |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| St Louis University | St Louis | Missouri | 63110 | United States |
| Mercury Street Medical Group | Butte | Montana | 59701 | United States |
| CHI St Elizabeth Hospital | Lincoln | Nebraska | 68510 | United States |
| Renown Health | Reno | Nevada | 89502 | United States |
| Dartmouth Hichcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| AtlantiCare Regional Medical Center | Atlantic City | New Jersey | 08401 | United States |
| Hope Tower at Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Capital Health System, Inc. | Trenton | New Jersey | 08638 | United States |
| Christus St. Vincent Regional Medical Center | Santa Fe | New Mexico | 87505 | United States |
| NYU Langone Hospital-Brooklyn | Brooklyn | New York | 111220 | United States |
| Coney Island Hospital | Brooklyn | New York | 11235 | United States |
| Buffalo General Medical Center | Buffalo | New York | 14203 | United States |
| Mercy Hospital Buffalo | Buffalo | New York | 14220 | United States |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | United States |
| New York University Langone Health | New York | New York | 10016 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Duke Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University/Vidant Health | Greenville | North Carolina | 27858 | United States |
| Wake Med Hospital | Raleigh | North Carolina | 27610 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Summa Health | Akron | Ohio | 44304 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Ascension St. John Bartlesville | Tulsa | Oklahoma | 74104 | United States |
| Ascension St. John Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| St. Luke's University Health Network | Easton | Pennsylvania | 18045 | United States |
| Conemaugh Memorial Medical Center | Johnstown | Pennsylvania | 15905 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Tower Health Medical Group | West Reading | Pennsylvania | 19611 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Christus St. Elizabeth Hospital | Beaumont | Texas | 77702 | United States |
| Baylor Scott and White Medical Center- College Station | College Station | Texas | 77845 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Texas Health Harris Methodist | Fort Worth | Texas | 76104 | United States |
| University of Texas- Houston, LBJ Hospital | Houston | Texas | 77030 | United States |
| UT Houston MHH-SW | Houston | Texas | 77030 | United States |
| UTHouston | Houston | Texas | 77030 | United States |
| Texas Health Frisco | Plano | Texas | 75024 | United States |
| Baylor Scott and White-Round Rock | Round Rock | Texas | 78665 | United States |
| Baylor Scott and White-Temple | Temple | Texas | 76508 | United States |
| The Woodlands Center For Respiratory & Sleep Research | The Woodlands | Texas | 77380 | United States |
| CHRISTUS Trinity Clinic Pulmonary Medicine | Tyler | Texas | 75701 | United States |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | United States |
| UT Health East Texas (Tyler) | Tyler | Texas | 75708 | United States |
| UT Rio Grande Valley | Weslaco | Texas | 78596 | United States |
| MultiCare Institute for Research & Innovation | Puyallup | Washington | 98372 | United States |
| UW Medicine Valley Medical Center | Renton | Washington | 98055 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| CAMC Clinical Trials Center | Charleston | West Virginia | 25304 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| Blood Center of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
| BG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Medical history of Deep Vein Thrombosis (DVT) | Count of Participants | Participants |
| ||||||||||||||||
| Medical History of Pulmonary Embolism (PE) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. | Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30. | intention-to-treat (ITT) population, including all participants randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days after hospital discharge |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score. | Composite endpoint of mortality and EQ5D index at Day 30. All mortality events will be considered worse than any possible EQ5D response [QOL&M30]. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility. | intention-to-treat (ITT) population, including all participants randomized | Posted | Median | Inter-Quartile Range | score on a scale | 30 days after hospital discharge |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Composite Outcome of All-cause Mortality and the EQ5D Index Score. | Composite endpoint of mortality and EQ5D index at Day 90. All mortality events will be considered worse than any possible EQ5D response. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility. | intention-to-treat (ITT) population, including all participants randomized | Posted | Median | Inter-Quartile Range | score on a scale | 90 days after hospital discharge |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. | intention-to-treat (ITT) population, including all participants randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 45 days after hospital discharge |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. | intention-to-treat (ITT) population, including all participants randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 90 days after hospital discharge |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records. | intention-to-treat (ITT) population, including all participants randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days after randomization (which occurred at time of hospital discharge) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records. | intention-to-treat (ITT) population, including all participants randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days after randomization (which occurred at time of hospital discharge) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With All-cause Mortality | intention-to-treat (ITT) population, including all participants randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days following discharge from hospital |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Incidence of All-cause Rehospitalization for up to 90 Days After Randomization | Not Posted | 90 days following discharge from hospital | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Individual Domains of EQ5D and the EQ5D Visual Analog Scale for 30 and 90 Days After Randomization | Not Posted | 30 and 90 days following discharge from hospital | Participants |
Up to the 90 day visit
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. | 12 | 610 | 71 | 610 | 80 | 610 |
| EG001 | Placebo | Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. | 9 | 607 | 66 | 607 | 90 | 607 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE APPENDICITIS | Infections and infestations | Systematic Assessment |
| ||
| ACUTE ASTHMA EXACERBATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ACUTE DIFFUSE MYALGIAS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| ACUTE REJECTION ON TRANSPLANTED KIDNEY | Immune system disorders | Systematic Assessment |
| ||
| ALCOHOL DETOXIFICATION | Surgical and medical procedures | Systematic Assessment |
| ||
| APPENDICITIS | Infections and infestations | Systematic Assessment |
| ||
| ASTHMA EXACERBATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
| ||
| ATYPICAL CHEST PAIN | General disorders | Systematic Assessment |
| ||
| BILATERAL LOWER EXTREMITY CELLULITIS | Infections and infestations | Systematic Assessment |
| ||
| BILATERAL PULMONARY EMBOLI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| BRONCHIOLITIS OBLITERANS ORGANIZING PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| C. DIFFICILE COLITIS | Infections and infestations | Systematic Assessment |
| ||
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
| ||
| CELLULITIS | Infections and infestations | Systematic Assessment |
| ||
| CHEST PAIN | General disorders | Systematic Assessment |
| ||
| CHRONIC SYSTOLIC HEART FAILURE | Cardiac disorders | Systematic Assessment |
| ||
| COMMUNITY ACQUIRED PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| COMPLEX MIGRAINES | Nervous system disorders | Systematic Assessment |
| ||
| COPD EXACERBATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COVID-19 PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 REINFECTION | Infections and infestations | Systematic Assessment |
| ||
| CRUSH INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| CYSTITIS | Infections and infestations | Systematic Assessment |
| ||
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
| ||
| DIABETIC KETO ACIDOSIS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| FOOT FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| GASTROINTESTINAL BLEED | Gastrointestinal disorders | Systematic Assessment |
| ||
| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
| ||
| GENERAL WEAKNESS | General disorders | Systematic Assessment |
| ||
| GI BLEED | Gastrointestinal disorders | Systematic Assessment |
| ||
| HEADACHES | Nervous system disorders | Systematic Assessment |
| ||
| HEMATEMESIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| HOSPITAL ACQUIRED PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| HYPERGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| LEFT LOWER EXTREMITY DVT | Vascular disorders | Systematic Assessment |
| ||
| LLE CELLULITIS | Infections and infestations | Systematic Assessment |
| ||
| LLE SUPERFICIAL THROMBOSIS | Vascular disorders | Systematic Assessment |
| ||
| MITRAL VALVE REGURGITATION | Cardiac disorders | Systematic Assessment |
| ||
| NEW ONSET DIABETES | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| NON-ST ELEVATED MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| ORTHOSTATIC HYPOTENSION | Vascular disorders | Systematic Assessment |
| ||
| OSTEOMYELITIS | Infections and infestations | Systematic Assessment |
| ||
| PANCREATITIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| POST COVID INFLAMMATORY LUNG DISEASE | Infections and infestations | Systematic Assessment |
| ||
| POST COVID-19 SYNDROME | Infections and infestations | Systematic Assessment |
| ||
| POST-COVID INFLAMMATORY SYNDROME | Infections and infestations | Systematic Assessment |
| ||
| POST-SURGICAL INTRA-ABDOMINAL INFECTION | Infections and infestations | Systematic Assessment |
| ||
| PULMONARY EMBOLI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SEIZURE | Nervous system disorders | Systematic Assessment |
| ||
| SEPTIC SHOCK | Infections and infestations | Systematic Assessment |
| ||
| SIALADENITIS | Infections and infestations | Systematic Assessment |
| ||
| SIGMOID DIVERTICULITIS | Infections and infestations | Systematic Assessment |
| ||
| SMALL BOWEL OBSTRUCTION | Gastrointestinal disorders | Systematic Assessment |
| ||
| ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| TENSION PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| TRANSIENT ISCHEMIC ATTACK | Nervous system disorders | Systematic Assessment |
| ||
| TRAUMATIC FOLEY INSERTION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| ULCERATIVE PROCTITIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| UNCONTROLLED DIABETES MELLITUS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| WORSENING ABSCESSES | Infections and infestations | Systematic Assessment |
| ||
| WORSENING COLLAGENOUS COLITIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| WORSENING COVID-19 INFECTION | Infections and infestations | Systematic Assessment |
| ||
| WORSENING COVID-19 PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| WORSENING INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| WORSENING PATHOLOGICAL FRACTURE OF PELVIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| WORSENING PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | Systematic Assessment |
| ||
| ABNORMAL BLEEDING | Vascular disorders | Systematic Assessment |
| ||
| ACUTE BACTERIAL SINUSITIS | Infections and infestations | Systematic Assessment |
| ||
| ACUTE PROSTATITIS | Reproductive system and breast disorders | Systematic Assessment |
| ||
| ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ANGIONEUROTIC EDEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| ANXIETY | Psychiatric disorders | Systematic Assessment |
| ||
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BALANITIS | Reproductive system and breast disorders | Systematic Assessment |
| ||
| BILATERAL KNEE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BILATERAL LEG EDEMA | General disorders | Systematic Assessment |
| ||
| BILATERAL LEG PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BILATERAL LEG SWELLING | General disorders | Systematic Assessment |
| ||
| BILATERAL LOWER EXTREMITY PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BRADYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| BRONCHITIS | Infections and infestations | Systematic Assessment |
| ||
| CELLULITIS | Infections and infestations | Systematic Assessment |
| ||
| CELLULITIS OF THE RIGHT LOWER EXTREMITY | Infections and infestations | Systematic Assessment |
| ||
| CERVICAL RADICULOPATHY | Nervous system disorders | Systematic Assessment |
| ||
| CHEST PAIN | General disorders | Systematic Assessment |
| ||
| CHEST TIGHTNESS | General disorders | Systematic Assessment |
| ||
| CHOLECYSTITIS | Hepatobiliary disorders | Systematic Assessment |
| ||
| COLITIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| COMMUNITY ACQUIRED PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| COMPLEX MIGRAINES | Nervous system disorders | Systematic Assessment |
| ||
| COMPLEX REGIONAL PAIN SYNDROME | Nervous system disorders | Systematic Assessment |
| ||
| CONCUSSION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| COPD EXACERBATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| COVID-19 CHRONIC DYSPNEA | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 PNEUMONITIS | Infections and infestations | Systematic Assessment |
| ||
| DECONDITIONED MUSCLES | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| DEHYDRATION | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| DENTAL PAIN | Gastrointestinal disorders | Systematic Assessment |
| ||
| DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| DIARRHEA | Gastrointestinal disorders | Systematic Assessment |
| ||
| EDEMA | General disorders | Systematic Assessment |
| ||
| ELEVATED D-DIMER | Investigations | Systematic Assessment |
| ||
| ELEVATED LIVER ENZYMES | Investigations | Systematic Assessment |
| ||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ESOPHAGEAL SPASM | Gastrointestinal disorders | Systematic Assessment |
| ||
| FACIAL DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| FALL | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| FAULTY OXYGEN EQUIPMENT | Product Issues | Systematic Assessment |
| ||
| GASTROESOPHAGEAL REFLUX | Gastrointestinal disorders | Systematic Assessment |
| ||
| GASTROINTESTINAL REFLUX | Gastrointestinal disorders | Systematic Assessment |
| ||
| GOUT | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| GROUND LEVEL FALL | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| HAIR LOSS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| HEMATOCHEZIA | Gastrointestinal disorders | Systematic Assessment |
| ||
| HEMATOMA | Vascular disorders | Systematic Assessment |
| ||
| HEMATURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| HEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| HORSESHOE TEAR OF RETINA WITHOUT DETACHMENT | Eye disorders | Systematic Assessment |
| ||
| HYPERGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERTENSION | Vascular disorders | Systematic Assessment |
| ||
| HYPOGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| INFLUENZA | Infections and infestations | Systematic Assessment |
| ||
| IRRITABLE BOWL SYNDROME | Gastrointestinal disorders | Systematic Assessment |
| ||
| LEFT ARM PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| LEFT LOWER EXTREMITY PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| LEFT PLEURITIC CHEST PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| LEFT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| LIPOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| LOWER EXTREMITY PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MILD LEFT SYSTOLIC DYSFUNCTION | Cardiac disorders | Systematic Assessment |
| ||
| MOTOR VEHICLE ACCIDENT | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| MOTOR VEHICLE VS PEDESTRIAN | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| NEPHROLITHIASIS | Renal and urinary disorders | Systematic Assessment |
| ||
| NON-INTRACTABLE HEADACHE | Nervous system disorders | Systematic Assessment |
| ||
| NON-OCCLUSIVE THROMBUS | Vascular disorders | Systematic Assessment |
| ||
| OTITIS MEDIA | Infections and infestations | Systematic Assessment |
| ||
| PALPITATIONS | Cardiac disorders | Systematic Assessment |
| ||
| PAROXYSMAL A-FIB | Cardiac disorders | Systematic Assessment |
| ||
| PARTIAL MURAL THROMBUS | Vascular disorders | Systematic Assessment |
| ||
| PERIVASCULAR DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PLEURISY | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PLEURITIC CHEST PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| POST ACUTE COVID-19 SYMPTOMS | Infections and infestations | Systematic Assessment |
| ||
| POST ACUTE COVID-19 SYNDROME | Infections and infestations | Systematic Assessment |
| ||
| POWER FLOW PORT EVALUATION | Surgical and medical procedures | Systematic Assessment |
| ||
| PRURITIC RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RENAL CALCULI | Renal and urinary disorders | Systematic Assessment |
| ||
| RESOLVING COVID-19 PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| RHEUMATOID ARTHRITIS FLARE UP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RIGHT HAND ABSCESS | Infections and infestations | Systematic Assessment |
| ||
| RIGHT KNEE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RIGHT LEG PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RIGHT LOWER EXTREMITY PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RIGHT RING FINGER LACERATION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RIGHT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SEIZURE | Nervous system disorders | Systematic Assessment |
| ||
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SUBSTERNAL CHEST PAIN | General disorders | Systematic Assessment |
| ||
| SUPERFICIAL GUN SHOT WOUND | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SUPERIOR LABRAL TEAR | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| TACHYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| TELOGEN EFFLUVIUM | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| TRIQUETRUM FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| TYPE II NSTEMI | Cardiac disorders | Systematic Assessment |
| ||
| UNCONTROLLED DIABETES | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| UPPER RESPIRATORY INFECTION | Infections and infestations | Systematic Assessment |
| ||
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| VASOVAGAL SYNCOPE | Nervous system disorders | Systematic Assessment |
| ||
| VIRAL SYNDROME | Infections and infestations | Systematic Assessment |
| ||
| WEAKNESS | General disorders | Systematic Assessment |
| ||
| WORSENING BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| WORSENING CHEST PAIN | General disorders | Systematic Assessment |
| ||
| WORSENING CORONARY ARTERY DISEASE | Cardiac disorders | Systematic Assessment |
| ||
| WORSENING COVID-19 PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| WORSENING DENTAL PAIN | Gastrointestinal disorders | Systematic Assessment |
| ||
| WORSENING DIABETIC FOOT ULCER | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| WORSENING HAND TREMOR | Nervous system disorders | Systematic Assessment |
| ||
| WORSENING HYPOXIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| WORSENING INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| WORSENING MOREL LAVALLEE LESION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| WORSENING NEPHROLITHIASIS | Renal and urinary disorders | Systematic Assessment |
| ||
| WORSENING PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| WORSENING VISION LOSS | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Ortel | Duke University Medical Center | 919-684-5350 | 3 | thomas.ortel@duke.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2022 | Mar 6, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Aboriginal or First Nations |
|
| Middle Eastern or North African |
|
| More than one race |
|
| Other Race |
|
| Unknown |
|
| OG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
|
|
| OG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
|
|
| OG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
|
|
| OG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
|
|
| OG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
|
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| OG001 | Apixaban | Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
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| OG001 |
| Apixaban |
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge. |
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