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COVID-19 pandemic
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to examine the degree to which pulmonary embolism (clot) can be dissolved when treated with a very low dose of a systemic thrombolytic drug (clot buster) along with standard anticoagulant therapy as compared to the standard of care anticoagulant therapy alone.
The OVERALL OBJECTIVE of this investigation is to determine whether very low-dose intravenous tissue-type plasminogen activator [tPA] (24 mg) + standard anticoagulation therapy (intravenous heparin) for treatment of acute PE (pulmonary embolism) in intermediate-high risk patients will have superior clot lysis (breakdown of clot) by chest CTA (computed tomography angiography) at 24 ± 6 hours post infusion compared to standard of care treatment alone. Acute intermediate-high risk PE patients are those with acute symptoms <14 days), simplified Pulmonary Embolism Severity Index (sPESI)>0, normal systemic arterial blood pressure (>90mmHg) without vasopressor support, elevated biomarkers (troponin or BNP), and evidence of RV dysfunction (right ventricular to left ventricular ratio>0.9).The study is planned to evaluate the reduction in clot burden based on the obstruction index using the Refined Modified Miller Score (RMMS), improvement in right ventricular (RV) function, and overall safety in the two treatment groups. 40 Subjects with intermediate-high risk PE (hemodynamically stable PE with a RV/LV ratio ≥ 0.9, elevated biomarkers, and sPESI>0) will be recruited and randomized to one of two treatment groups: 24mg of systemic (IV) tPA + IV unfractionated heparin versus saline placebo + IV unfractionated heparin. After delivery of the systemic (IV) tPA/placebo, patients will continue IV unfractionated heparin therapy for at least 24 hours. If there is no evidence of active bleeding nor significant hemoglobin drop (i.e., ≥ 2 mg/dL), patients will be transitioned to standard dose apixaban, 10 mg twice-daily x one week followed by 5 mg twice-daily for at least 6 months. Some patients will require indefinite apixaban therapy based on patient-specific factors, including unprovoked nature of PE event, and/or persisting DVT/PE risk factors. Finally, consideration will be given for decreasing the apixaban dose to 2.5 mg twice-daily after 6 months. Apixaban was selected as the anticoagulant of choice due to its very favorable bleeding profile in large clinical trials, which is an important consideration when prescribing an anticoagulant following systemic thrombolysis. Within 24 ± 6 hours post study drug infusion, a repeat chest CTA and echocardiogram will be performed. sPESI will also be calculated at this timepoint.At Day 30, 180 and 365, all subjects will have clinic visits which will include a physical exam, repeat echocardiogram if previous echo was abnormal, 6 minute walk test (6MWT), quality of life questionnaires, assessment of adverse and bleeding events and a review of concomitant medications including compliance with apixaban. At Days 3, 7, 90 and 270, a remote health check will occur via telephone or email assessing adverse and bleeding events, alongside a review of concomitant medications (including an assessment of compliance with apixaban).The standard of care for patients with submassive PE is to either receive anticoagulant therapy, EKOS (Catheter Assisted Thrombolysis) or thromboectomy. tPA is given at the FDA approved dose (100mg) occasionally at doses much higher than our study proposes. PatientS with PE will have the initial CTA, echocardiogram and lab work as standard of care. The follow up CTA is usually standard of care at Day 30 and the follow up echocardiograms are considered standard of care if the previous echocardiogram was abnormal.The study is being done as a proof of concept that low dose tPA is effective in clot lysis and will result in far less risk than the FDA dose. If our study achieves its aims, the research will advance clinical practices in treating pulmonary embolism by reporting the safety of lower dose tPA and opening opportunities to further explore the use of lower dose tPA to improve patient safety and outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alteplase & Unfractionated Heparin & Apixaban | Experimental | Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. |
|
| Placebo & Unfractionated Heparin & Apixaban | Active Comparator | Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase | Drug | Lyophilized powder for reconstitution in 50mg vials |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Extent of Clot Lysis in the Experimental Arm | Change in percentage of clot lysis in the experimental arm only as measured using the Refined Modified Miller Score (RMMS) from the baseline CTA to the 24 hour CTA after 24mg of systemic (IV) tPA + standard anticoagulation therapy (experimental arm). | Baseline, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Extent of Clot Lysis Between the Experimental Arm and the Active Comparator Arm | Change in percentage of clot lysis between the experimental arm and the active comparator arm as measured using the Refined Modified Miller Score (RMMS) from the baseline CTA to the 24 hour CTA after 24mg of systemic (IV) tPA + standard anticoagulation therapy (experimental arm) compared to 24mg of systemic (IV) placebo + standard anticoagulation therapy (active comparator arm). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor F Tapson, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Aaron S Weinberg, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22179539 | Background | Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. | |
| 20331949 |
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The study was terminated early and never unblinded. Arm/Group randomization information is not available.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Participants were randomly assigned to either:
Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2019 |
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| Unfractionated heparin | Drug | Heparin sodium in 0.45% sodium chloride injection for intravenous use |
|
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| Placebo | Drug | Saline solution reconstituted to mimic Alteplase 50mg vial |
|
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| Apixaban | Drug | Apixaban tablet |
|
|
| Baseline, 24 hours |
| Change in Right Ventricular to Left Ventricular Diameter (RV/LV) Ratio | RV/LV ratio as measured by chest CTA from baseline to 24 ± 6 hours after the infusion of very low dose systemic (IV) tPA in patients with acute intermediate-high risk PE compared with placebo. | Baseline, 24 hours |
| Change in RV/LV Ratio From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the RV/LV ratio within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Baseline, 24 hours and 30 days |
| Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the tricuspid annular plane systolic excursion (TAPSE) within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Baseline, 24 hours and 30 days |
| Change in Right Ventricular Systolic Pressure (RVSP) From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the estimated right ventricular systolic pressure (RVSP) within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Baseline, 24 hours and 30 days |
| Change in the Collapse of the Inferior Vena Cava (IVC) From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the collapse of the inferior vena cava (IVC) with respiration within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Baseline, 24 hours and 30 days |
| Change in the Requirement for Oxygen Therapy After 6 Minute Walk Test (6MWT) | 6MWT distance as measured by the requirement for oxygen therapy at 30 day, 60 day and one year ± 14 days clinic follow-up compared with placebo. | 30 days, 60 days, and 1 year |
| Change in Borg Dyspnea Scale Score After 6 Minute Walk Test (6MWT) | 6MWT distance as measured by the Borg Dyspnea Scale score (Borg score) at 30 day, 60 day and one year ± 14 days clinic follow-up compared with placebo. The Borg Scale measures self-reported intensity and severity of breathlessness (dyspnea) and fatigue before, during, and after a 6MWT. Each item is scored 0 - 10 (0 = no breathlessness at all; 10 = most severe breathlessness that you have ever experienced), yielding a total between 0 and 20. | 30 days, 60 days, and 1 year |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Questionnaire | Quality of life (QOL) as measured by the PROMIS PF-6at 30 days, 6 months and one year ± 14 days clinic follow-up compared with placebo. The PROMIS PF-6 measures self-reported physical function for everyday tasks (i.e., yard work, shopping, walking up/down stairs). Each item is score 1 - 5 (1 = unable to do/cannot do; 5 = without any difficulty/not at all), yielding a total between 6 and 30. | 30 days, 6 months, and 1 year |
| Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Questionnaire | Quality of life (QOL) as measured by the PEmb-QOL at 30 days, 6 months and one year ± 14 days clinic follow-up compared with placebo. The PEmb-QOL measures self-reported QOL after a Pulmonary Embolism. The PEmb-QOL has nine sub-scales with higher scores indicating worse outcomes. Each item is score 1 - 5 (1 = unable to do/cannot do; 5 = without any difficulty/not at all), yielding a total between 6 and 30. | 30 days, 6 months, and 1 year |
| Number of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) Events | Measured as the number of recurrent DVT and/or PE events in patients at 30 days, 60 days, 6 months, and 1 year compared to placebo. | 30 days, 60 days, 6 months, and 1 year |
| Background |
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| Background | R Core Team (2018). A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. |
| COMPLETED |
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| NOT COMPLETED |
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The study was closed prematurely due to covid-19. Unblinding was not done and analysis was not performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were randomly assigned to either: Alteplase & Unfractionated Heparin & Apixaban Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet OR Placebo & Unfractionated Heparin & Apixaban Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gender | Count of Participants | Participants |
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| 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 | Change in Extent of Clot Lysis in the Experimental Arm | Change in percentage of clot lysis in the experimental arm only as measured using the Refined Modified Miller Score (RMMS) from the baseline CTA to the 24 hour CTA after 24mg of systemic (IV) tPA + standard anticoagulation therapy (experimental arm). | The study was terminated early and never unblinded. Data was not analyzed. | Posted | Baseline, 24 hours |
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| Secondary | Change in Extent of Clot Lysis Between the Experimental Arm and the Active Comparator Arm | Change in percentage of clot lysis between the experimental arm and the active comparator arm as measured using the Refined Modified Miller Score (RMMS) from the baseline CTA to the 24 hour CTA after 24mg of systemic (IV) tPA + standard anticoagulation therapy (experimental arm) compared to 24mg of systemic (IV) placebo + standard anticoagulation therapy (active comparator arm). | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | Baseline, 24 hours |
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| Secondary | Change in Right Ventricular to Left Ventricular Diameter (RV/LV) Ratio | RV/LV ratio as measured by chest CTA from baseline to 24 ± 6 hours after the infusion of very low dose systemic (IV) tPA in patients with acute intermediate-high risk PE compared with placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | Baseline, 24 hours |
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| Secondary | Change in RV/LV Ratio From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the RV/LV ratio within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | Baseline, 24 hours and 30 days |
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| Secondary | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the tricuspid annular plane systolic excursion (TAPSE) within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | Baseline, 24 hours and 30 days |
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| Secondary | Change in Right Ventricular Systolic Pressure (RVSP) From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the estimated right ventricular systolic pressure (RVSP) within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | Baseline, 24 hours and 30 days |
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| Secondary | Change in the Collapse of the Inferior Vena Cava (IVC) From Baseline Echocardiogram | Change from baseline in echocardiographic parameters as measured by the collapse of the inferior vena cava (IVC) with respiration within 24 hours ± 6 hours and at 30 ± 5 days after the end of the systemic (IV) tPA infusion compared with placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | Baseline, 24 hours and 30 days |
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| Secondary | Change in the Requirement for Oxygen Therapy After 6 Minute Walk Test (6MWT) | 6MWT distance as measured by the requirement for oxygen therapy at 30 day, 60 day and one year ± 14 days clinic follow-up compared with placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | 30 days, 60 days, and 1 year |
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| Secondary | Change in Borg Dyspnea Scale Score After 6 Minute Walk Test (6MWT) | 6MWT distance as measured by the Borg Dyspnea Scale score (Borg score) at 30 day, 60 day and one year ± 14 days clinic follow-up compared with placebo. The Borg Scale measures self-reported intensity and severity of breathlessness (dyspnea) and fatigue before, during, and after a 6MWT. Each item is scored 0 - 10 (0 = no breathlessness at all; 10 = most severe breathlessness that you have ever experienced), yielding a total between 0 and 20. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | 30 days, 60 days, and 1 year |
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| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Questionnaire | Quality of life (QOL) as measured by the PROMIS PF-6at 30 days, 6 months and one year ± 14 days clinic follow-up compared with placebo. The PROMIS PF-6 measures self-reported physical function for everyday tasks (i.e., yard work, shopping, walking up/down stairs). Each item is score 1 - 5 (1 = unable to do/cannot do; 5 = without any difficulty/not at all), yielding a total between 6 and 30. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | 30 days, 6 months, and 1 year |
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| Secondary | Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Questionnaire | Quality of life (QOL) as measured by the PEmb-QOL at 30 days, 6 months and one year ± 14 days clinic follow-up compared with placebo. The PEmb-QOL measures self-reported QOL after a Pulmonary Embolism. The PEmb-QOL has nine sub-scales with higher scores indicating worse outcomes. Each item is score 1 - 5 (1 = unable to do/cannot do; 5 = without any difficulty/not at all), yielding a total between 6 and 30. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | 30 days, 6 months, and 1 year |
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| Secondary | Number of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) Events | Measured as the number of recurrent DVT and/or PE events in patients at 30 days, 60 days, 6 months, and 1 year compared to placebo. | Data analysis not done because study closed early due to COVID-19 and there were only 4 subjects enrolled. With only 4 subjects, we decided not to unblind due to the sample size being so small that statistical significance could never be demonstrated. | Posted | 30 days, 60 days, 6 months, and 1 year |
|
Adverse events were collected up to 8.5months given patient safety concerns due to the COVID-19 pandemic. The original Adverse Event assessment per the protocol was 1 year from baseline.
Study was not unblinded. All data was entered in the treatment fields.
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 | All Study Participants | Participants were randomly assigned to either: Alteplase & Unfractionated Heparin & Apixaban Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet OR Placebo & Unfractionated Heparin & Apixaban Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months. Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet | 1 | 4 | 2 | 4 | 1 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AKI and Anemia | Renal and urinary disorders | Systematic Assessment | Kidney injury which he also has a long history of since 2015. Found to have anemia with a Hgb of 6.5 (He was given a unit of PRBCs and increased to 8.4). CT abdomen showed no major pathology. He did have fecal impaction at other hospital. |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient experienced respiratory failure and patient's family decided to make him DNR. He was placed in hospice facility and died a few days later. |
| |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Found to have anemia with Hgb of 6.5. He was given a unit of PRBC's and increased 8.4. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment | Headache after TNK administration |
| |
| Eye pain | Eye disorders | Systematic Assessment | Patient had pain in right eye that was sharp in nature. No loss of vision although patient stated that over the last 6 mo the patient felt slight decreased visual acuity bilaterally. |
| |
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Suspected bleed | Blood and lymphatic system disorders | Systematic Assessment | Unknown drop of hemoglobin requiring transfusion |
| |
| Bruising on chest | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| increased shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Suspected bleed | Blood and lymphatic system disorders | Systematic Assessment | seems to be related to ulceration on palate which was noted during hospital stay |
| |
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Suspected bleed | Blood and lymphatic system disorders | Systematic Assessment | bleeding of gums from toothbrushing |
| |
| worsening back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | worsening with bending down-- chest CTA showed clot burden in lungs. |
| |
| left groin pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | discomfort in groin that feels like a twisting and jolt |
| |
| palpitations | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Enrollment was held and study closed prematurely due to COVID-19 pandemic. We were otherwise hopeful to enroll and complete all assessments for this study.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor Tapson | Cedars-Sinai Medical Center | 919-971-6441 | Victor.Tapson@cshs.org |
| Feb 11, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2019 | Feb 11, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D018497 | Ventricular Dysfunction, Right |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D006493 | Heparin |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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