Rivaroxaban for the prevention of major cardiovascular events in coronary or peripheral artery disease

• Conditions: Prevention of major cardiovascular events in patients with coronary or peripheral artery disease; MedDRA version: 14.1Level: PTClassification code 10064939Term: Cardiovascular event prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-004180-43-IT
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-28
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 21500

Inclusion Criteria

Coronary or peripheral artery disease plus at least one of the following:
•Age =65
•Age <65 plus documented atherosclerosis in at least two vascular beds or at least 2 additional cardiovascular risk factors
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13975
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7525

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified