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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 29940

Inclusion Criteria

- Willing and able to provide written informed consent
- Meet criteria for CAD* and/or PAD
*Subjects with CAD must also meet at least one of the following:
•Age =65, or
•Age <65 plus documented atherosclerosis or revascularisation involving at least two vascular beds or at least 2 additional cardiovascular risk factors :
1) Current smoker (within 1 year or fandomisation)
2) Diabetes mellitus
3) Renal dysfunction with estimated glomerular filtration rate <60 ml/min
4) Heart failure
5) Non-lacunar ischemic stroke = 1 month ago
§Because CAD involves disease in the coronary vasculature, only one additional vascular bed is required:e.g. the aorta and arterial supply to the brain, gastro-intestinal tract, lower limbs, upper limbs, or kidneys.

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 4491
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25449

Exclusion Criteria

- High risk of bleeding
- 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
- Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions.
- History of hypersensitivity or known contraindication for rivaroxaban, aspirin, pantoprazole, or excipients, if applicable.
- Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (P-gp) (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
- Any known hepatic disease associated with coagulopathy
- Subjects who are pregnant, breastfeeding or are of childbearing potential, and sexually active and not practicing an effective method of birth control (e.g. surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization)
- Previous assignment to treatment during this study
- Concomitant participation in another study with investigational drug
- Known contraindication to any study related procedures
An additional exclusion for the pantoprazole randomization is:
- Need for continuous treatment with a proton pump inhibitor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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