Cardiovascular OutcoMes for People Using Anticoagulation StrategieS
Randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with CAD or PAD. If participant not currently on PPI, randomization to pantoprazole/placebo for the reduction of gastrointestinal bleeding, ulceration, and gastrointestinal obstruction or perforation in subjects with CAD or PAD receiving antithrombotic medications.
Randomized, blinded, partial factorial, 3×2, parallel group design, multicenter, event-driven study. All patients must successfully complete a 4-week run-in phase on low-dose of rivaroxaban prior to being randomized.
Primary efficacy outcome: Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death, over approximately 5 years
Primary safety outcome: Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis), over approximately 5 years
Stuart Connolly, John Eikelboom
Astrid Cuncins-Hearn, Kevin Reeh, Jane Belanger