A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes. The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With or Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome).

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes. The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With or Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome).

Completed
Phase of Trial: Phase II

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Rivaroxaban (Primary)
  • Indications Acute coronary syndromes; Embolism and thrombosis
  • Focus Adverse reactions; Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Acronyms ATLAS-ACS-TIMI-46
  • Sponsors Bayer
  • Most Recent Events

    • 30 Jun 2012 Planned number of patients changed from 3600 to 6625 as reported by European Clinical Trials Database.
    • 22 Mar 2011 New source identified and integrated (Australian New Zealand Clinical Trials Registry; ACTRN12607000405415).
    • 16 Nov 2009 Results of substudy investigating effects on markers of coagulation presented at the 82nd Annual Scientific Sessions of the American Heart Association (AHA).
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