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| ID | Type | Description | Link |
|---|---|---|---|
| 39039039APE4001 | Other Identifier | Janssen Scientific Affairs, LLC |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants who are discharged from the Emergency Department (ED) to the home environment and treated with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or venous thromboembolism (VTE) events through Day 30 compared to participants who are treated with initial hospitalization and standard-of-care.
This is a randomized (study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group, multicenter (study conducted at multiple sites) study to evaluate that low risk PE participants who are discharged from the ED and treated with rivaroxaban compared to participants who are treated with initial hospitalization and standard-of-care. The study consists of a Screening and Randomization Period, followed by a 90-day open-label treatment period, and an end of study/early withdrawal (EOS) visit. The duration of study participation for each participant is approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two treatments. Safety will be monitored during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental | Participants will receive Rivaroxaban 15 milligram (mg) orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food, for approximately 69 days for a total treatment duration of 90 days. |
|
| local Standard-of-care | Experimental | Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration of Hospitalization | Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated. | Up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death | Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed. | Up to 7, 14, 30, and 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | United States | ||||
Of the 300 participants screened, 114 participants were randomized (51 to rivaroxaban group and 63 participants in the standard-of-care group) and 112 participants were treated and received at least 1 dose of study agent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivaroxaban | Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally. |
| FG001 | Standard-of-care |
| 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 | Jun 16, 2015 | Mar 21, 2018 |
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| Standard-of-care | Drug | Standard-of-care as per local protocol and defined by the medical team caring for the participant. |
|
| Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding | Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed. | Up to 7, 14, 30 and 90 Days |
| Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason | Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed. | Up to 30 and 90 Days |
| Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) | ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.](streamdown:incomplete-link) | Day 90 |
| Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire | The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction. | Day 7 |
| Chandler |
| Arizona |
| United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Los Angeles | California | United States |
| Sacramento | California | United States |
| Sylmar | California | United States |
| New Haven | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Pensacola | Florida | United States |
| Tampa | Florida | United States |
| Davenport | Iowa | United States |
| Iowa City | Iowa | United States |
| Baltimore | Maryland | United States |
| Springfield | Massachusetts | United States |
| Detroit | Michigan | United States |
| Jackson | Michigan | United States |
| Lansing | Michigan | United States |
| Royal Oak | Michigan | United States |
| St Louis | Missouri | United States |
| Atlantic City | New Jersey | United States |
| Camden | New Jersey | United States |
| Brooklyn | New York | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Stony Brook | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Durham | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Toledo | Ohio | United States |
| Zanesville | Ohio | United States |
| Portland | Oregon | United States |
| Allentown | Pennsylvania | United States |
| Bethlehem | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Charlottesville | Virginia | United States |
| Bellingham | Washington | United States |
| Everett | Washington | United States |
| Spokane | Washington | United States |
| Tacoma | Washington | United States |
Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivaroxaban | Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally. |
| BG001 | Standard-of-care | Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Mean Duration of Hospitalization | Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated. | The intention to treat analysis set (ITT) included all participants who were randomized into the study. | Posted | Mean | Standard Deviation | Days | Up to Day 30 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death | Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed. | The ITT included all participants who were randomized into the study. | Posted | Number | Percentage of participants | Up to 7, 14, 30, and 90 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding | Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed. | The ITT included all participants who were randomized into the study. | Posted | Number | Percentage of Participants | Up to 7, 14, 30 and 90 Days |
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| Secondary | Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason | Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed. | The ITT included all participants who were randomized into the study. | Posted | Mean | Standard Deviation | Days | Up to 30 and 90 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) | ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.](streamdown:incomplete-link) | The safety population included all randomized participants who took at least 1 dose of study drug. | Posted | Number | Percentage of participants | Day 90 |
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| Secondary | Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire | The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction. | The safety population included all randomized participants who took at least 1 dose of study drug. | Posted | Number | Percentage of participants | Day 7 |
|
Approximately 2.5 years
The safety population included all randomized participants who took at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rivaroxaban | Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally. | 0 | 49 | 5 | 49 | 15 | 49 |
| EG001 | Standard-of-care | Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants. | 0 | 63 | 7 | 63 | 13 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Embolic Pneumonia | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| May-Thurner Syndrome | Vascular disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen Scientific Affairs, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2017 | Mar 21, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Hispanic or Latino |
|
| Other |
|
| White |
|
| Not Hispanic or Latino |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|