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Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)

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ClinicalTrials.gov Identifier: NCT01776424
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Results First Posted : October 5, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE January 28, 2013
Results First Submitted Date  ICMJE July 16, 2018
Results First Posted Date  ICMJE October 5, 2018
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE February 28, 2013
Actual Primary Completion Date July 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death [ Time Frame: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
  • The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria [ Time Frame: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 5 years ]
  • Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 5 years ]
Change History Complete list of historical versions of study NCT01776424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death [ Time Frame: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
  • The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death [ Time Frame: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
  • All-cause Mortality [ Time Frame: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, venous thromboembolism or cardiovascular hospitalization [ Time Frame: Approximately 5 years ]
  • Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Official Title  ICMJE A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
Brief Summary

The primary objectives of this study are:

  • To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
  • To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prevention & Control
Intervention  ICMJE
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    Rivaroxaban 2.5 mg twice daily, tablet
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    Rivaroxaban 5.0 mg twice daily, tablet
  • Drug: Aspirin
    Aspirin 100 mg once daily, tablet
  • Drug: Aspirin placebo
    Placebo(1), matching Aspirin tablets
  • Drug: Rivaroxaban placebo
    Placebo(2), matching Rivaroxaban tablets
  • Drug: Pantoprazole
    Subjects who are not on a proton pump inhibitor (PPI) will also be randomized to pantoprazole or pantoprazole placebo
Study Arms  ICMJE
  • Experimental: Rivaroxaban [2.5mg] + Aspirin
    Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. (Long-term open-label extension was added to make rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.)
    Interventions:
    • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    • Drug: Aspirin
    • Drug: Pantoprazole
  • Experimental: Rivaroxaban [5mg] + Placebo(1)
    Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
    Interventions:
    • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    • Drug: Aspirin placebo
    • Drug: Pantoprazole
  • Active Comparator: Aspirin + Placebo(2)
    Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily
    Interventions:
    • Drug: Aspirin
    • Drug: Rivaroxaban placebo
    • Drug: Pantoprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
27395
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2013)
19500
Estimated Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date July 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-- Coronary or peripheral artery disease

Patients with coronary artery disease must also meet at least one of the following:

  • Age ≥65, or
  • Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors

Exclusion Criteria:

  • Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
  • Stroke within 1 month or any history of hemorrhagic or lacunar stroke
  • Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
  • Estimated glomerular filtration rate (eGFR)<15 mL/min
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   Ecuador,   Finland,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01776424
Other Study ID Numbers  ICMJE 15786
2012-004180-43 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE
  • Population Health Research Institute
  • Janssen Research & Development, LLC
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP