Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: Rivaroxaban/Placebo (Drug); Placebo (Drug); Rivaroxaban (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)
Secondary outcome: The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or StrokeThe Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke The Number of Deaths (All Cause) The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring
within 7 days of randomization
- Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial
infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an
abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature
Exclusion Criteria:
- Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within
the skull enclosing the brain)
- Need for continued anticoagulant therapy
- Significantly impaired renal (kidney) or hepatic (liver) function
- Severe concomitant diseases such as cardiogenic shock (heart damage that results in
insufficient blood supply to other parts or organs of the body), refractory
ventricular arrhythmias (irregular contractions of the heart unresponsive to
treatment), or any severe condition that would limit life expectancy of the patient
to less than 6 months
Locations and Contacts
Additional Information
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Starting date: November 2006
Last updated: September 28, 2012
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