Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\- Meet criteria for CAD and/or PAD
Subjects with CAD must also meet at least one of the following criteria:
Age ≥65, or
Age \<65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors

Criterios de exclusión

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
Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy

Intervenciones

drug

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 2.5 mg, twice daily, oral

drug

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 5 mg, twice daily, oral

drug

Aspirin

Tablet, 100 mg, once daily, oral

drug

Aspirin placebo

Aspirin matching placebo, once daily, oral

drug

Rivaroxaban placebo

Rivaroxaban matching placebo, twice daily, oral

drug

Pantoprazole

Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole

drug

Pantoprazole placebo

Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo

Ubicaciones

Adrogué, Buenos Aires, Argentina

Bahía Blanca, Buenos Aires, Argentina

Coronel Suárez, Buenos Aires, Argentina

Junín, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

Merlo, Buenos Aires, Argentina

Munro, Buenos Aires, Argentina

Quilmes, Buenos Aires, Argentina

Ramos Mejía, Buenos Aires, Argentina

San Martín, Buenos Aires, Argentina

San Nicolás de los Arroyos, Buenos Aires, Argentina

Vicente López, Buenos Aires, Argentina

Zárate, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Villa Allende, Córdoba Province, Argentina

Villa María, Córdoba Province, Argentina

Santa Rosa, La Pampa Province, Argentina

Rafaela, Santa Fe Province, Argentina

Rosario, Santa Fe Province, Argentina

Venado Tuerto, Santa Fe Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Ciudad Auton. de Buenos Aires, Argentina

Corrientes, Argentina

Córdoba, Argentina

Salta, Argentina

San Juan, Argentina

San Luis, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalBayer

ColaboradorPopulation Health Research Institute

ColaboradorJanssen Research & Development, LLC

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).

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban (Xarelto, BAY59-7939)

Aspirin

Aspirin placebo

Rivaroxaban placebo

Pantoprazole

Pantoprazole placebo

Ubicaciones

Patrocinadores