Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent
      acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the
      occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions,
      stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.
    

Detailed description: 
      This is a randomized (patients will be assigned to study treatment by chance), double-blind
      (neither the patient nor the study doctor will know the identity of the assigned study
      treatment) study to evaluate the safety and efficacy of rivaroxaban (study drug) compared to
      placebo (a tablet identical in appearance to study drug but contains no active drug) in
      patients with acute coronary syndrome (ACS [a condition where blood flow in a blood vessel in
      the heart is restricted because of a blood clot]). Rivaroxaban is a drug that acts as a blood
      thinner and is being tested to see if it will be safe and effective in patients diagnosed
      ACS. The goal of this study is to identify the dose and dosing schedule (once-a-day or
      twice-a-day dosing) of rivaroxaban that will be safe and effective in preventing adverse
      cardiovascular outcomes such as death, myocardial infarctions (MI) including repeat
      myocardial infarction (reMI), stroke, or ischemia (inadequate blood supply to a local area)
      requiring revascularization (ie, the re-establishment of blood supply to a part or an organ)
      in patients with ACS who are receiving antiplatelet therapy (ie, aspirin alone or aspirin
      plus an approved thienopyridine, a type of drug such as clopidogrel that acts to inhibit the
      formation of blood clots). Approximately 3500 patients are planned to participate in the
      study for approximately 7 months. At study entry, all patients who are currently receiving
      treatment for ACS with antiplatelet therapy will be permitted to continue this therapy during
      the study. Patients will be enrolled and randomized to receive placebo, rivaroxaban
      administered as a once-daily dose, or rivaroxaban administered as a twice-daily dose at each
      dose level of rivaroxaban tested. Patients randomized at each dose level will continue to
      receive the same treatment for 6 months. Near the end of enrollment at the first dose level,
      available safety and efficacy data from patients will be assessed by an Operations Committee
      before enrolling and randomizing additional patients to the next higher dose level of
      rivaroxaban. Increasing dose levels of rivaroxaban are planned; however, progression to each
      higher dose level will be at the discretion of the Operations Committee. Patient safety will
      be monitored by evaluating adverse events reported, results from clinical laboratory tests,
      findings from electrocardiograms (ECGs) and vital signs measurements, findings from physical
      examinations, and the number of patients with protocol-defined major or minor bleeding, or
      bleeding requiring medical attention. All patients will take study drug or placebo tablets
      orally (by mouth) twice daily for 6 months starting at an initial total daily dose of 5 mg.
      Both once- and twice-daily dosing regimens will be tested at each rivaroxaban dose level
      planned.
    

Intervention name(s): Rivaroxaban/Placebo; Placebo; Rivaroxaban
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.; 1 placebo tablet twice daily for 6 months.; 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Coronary Syndrome (ACS); Myocardial Ischemia; Rivaroxaban (BAY59-7939); Anti-platelet agents; Aspirin; Thienopyridine; Clopidogrel