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)

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

NL-OMON

Registry ID

NL-OMON47095

Enrollment

1350

Registered

2013-05-07

Start date

2013-07-31

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

coronary and peripheral artery disease

Interventions

Treatment with rivaroxaban or placebo, aspirine or placebo, pantoprazole or placebo. LTOLE: bi daily 2.5mg rivaroxaban and once daily 100mg aspirine

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: CAD or PAD (see protocol for definitions) plus at least one of the following: o Age *65 o Age

Exclusion criteria

Exclusion criteria: - High risk of bleeding - Stroke within 1 month or any history of hemorrhagic or lacunar stroke - Ejection fraction

Design outcomes

Primary

Measure	Time frame
Efficacy: Composite of myocardial infarction, stroke, or cardiovascular death. Safety: modified International Society on Thrombosis and Haemostasis major bleeding. LTOLE: the same primary safety and efficacy variables will be collected.	—

Secondary

Measure	Time frame
Composite of myocardial infarction, stroke, cardiovascular death, revasculatization and venous thromboembolism and cardiovascular hospitalization. Mortality. Upper gastrointestinal bleeding, ulceration, and gastrointestinal obstruction or perforation.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)