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) - COMPASS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004180-43-IE

Enrollment

27400

Registered

2013-01-10

Start date

2013-03-13

Completion date

Unknown

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of major cardiovascular events in patients with coronary or peripheral artery disease MedDRA version: 18.0 Level: PT Classification code 10064939 Term: Cardiovascular event prophylaxis System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Xarelto Product Name: rivaroxaban 2.5 mg Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY

Eligibility

Sex/Gender

All

Inclusion criteria

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 years) yes F.1.3.1 Number of subjects for this age range 19975

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Approximately 5 years;Main Objective: Primary objectives for rivaroxaban randomization: •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 CAD or 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 ;Secondary Objective: Secondary objectives for rivaroxaban randomization: •To determine whether each of rivaroxaban 2.5 mg bid + aspirin 100 mg od and rivaroxaban 5 mg bid alone reduces the risk of the composite of major thrombotic events (myocardial infarction, stroke, cardiovascular death, revascularization, and venous thromboembolism) and cardiovascular hospitalization compared with aspirin 100 mg od in subjects with CAD or PAD •To determine whether each of rivaroxaban 2.5 mg bid + aspirin 100 mg od and rivaroxaban 5 mg bid alone reduces the risk of mortality in subjects with CAD or PAD ;Primary end point(s): Efficacy end point: Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death Safety end point: Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Approximately 5 years;Main Objective: Primary objectives for rivaroxaban randomization: •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 CAD or 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 ;Secondary Objective: Secondary objectives for rivaroxaban randomization: •To determine whether each of rivaroxaban 2.5 mg bid + aspirin 100 mg od and rivaroxaban 5 mg bid alone reduces the risk of the composite of major thrombotic events (myocardial infarction, stroke, cardiovascular death, revascularization, and venous thromboembolism) and cardiovascular hospitalization compared with aspirin 100 mg od in subjects with CAD or PAD •To determine whether each of rivaroxaban 2.5 mg bid + aspirin 100 mg od and rivaroxaban 5 mg bid alone reduces the risk of mortality in subjects with CAD or PAD ;Primary end point(s): Efficacy end point: Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death Safety end point: Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)

—

Secondary

Measure	Time frame
Secondary end point(s): Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, revascularization, venous thromboembolism, and cardiovascular hospitalization Time from randomization to first occurrence of all cause mortality;Timepoint(s) of evaluation of this end point: Approximately 5 years	—

Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Russian Federation, Slovakia, South Africa, Sweden, Switzerland, Ukraine, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026