An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Myocardial Ischemia; Unstable Angina; Acute Coronary Syndrome; Myocardial Infarction

Treatments: Drug: Rivaroxaban 2.5 mg; Drug: Standard of care; Drug: Rivaroxaban 5 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809965

RIVAROXACS3001 (Other Identifier)

CR014710

Details and patient eligibility

About

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Full description

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Enrollment: 15,526 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
• Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion criteria

• Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
• Need for continued anticoagulant therapy
• Significant renal impairment or known significant liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15,526 participants in 3 patient groups, including a placebo group

Rivaroxaban 2.5 mg bid

Experimental group

Description:

One 2.5 mg rivaroxaban tablet twice daily for up to 6 months

Treatment:

Drug: Rivaroxaban 2.5 mg

Drug: Standard of care

Rivaroxaban 5 mg bid

Experimental group

Description:

One 5 mg rivaroxaban tablet twice daily for up to 6 months

Treatment:

Drug: Rivaroxaban 5 mg

Drug: Standard of care

Placebo

Placebo Comparator group

Description:

One placebo tablet twice daily for up to 6 months

Treatment:

Drug: Standard of care

Drug: Placebo