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

Recruiting in Palo Alto (17 mi)

+581 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Eligibility Criteria

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

Treatment Details

Interventions

• Placebo (Drug)
• Rivaroxaban (Anticoagulant)
• Standard of care (Drug)

Participant Groups

Group I: Rivaroxaban 5 mg bid Experimental Treatment 2 Interventions

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

Group II: Rivaroxaban 2.5 mg bid Experimental Treatment 2 Interventions

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

Group III: Placebo Placebo Group 2 Interventions

One placebo tablet twice daily for up to 6 months

Who Is Running the Clinical Trial?

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Lead Sponsor

Trials

515

Recruited

845,000+

Joaquin Duato

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. John Reed

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Chief Medical Officer since 2023

MD from the University of Pennsylvania School of Medicine

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD