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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776424
First Posted: January 28, 2013
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
January 24, 2013
January 28, 2013
September 26, 2017
February 28, 2013
July 21, 2017   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01776424 on ClinicalTrials.gov Archive Site
  • Time from randomization to first occurrence of either Coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 5 years ]
  • Time from randomization to first occurrence of either Cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 5 years ]
  • Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ]
  • 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 ]
Not Provided
Not Provided
 
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
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).
The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prevention &Amp; Control
  • 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 PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
  • Experimental: Rivaroxaban [2.5mg] + Aspirin
    Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
    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
Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Störk S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
27395
March 31, 2018
July 21, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic
 
NCT01776424
15786
2012-004180-43 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bayer
Bayer
  • Hamilton Health Sciences Corporation, Population Health Research Institute
  • Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
Bayer
September 2017

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