A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Clopidogrel; Prasugrel; Commercially-available Aspirin
Intervention description: 300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study; 30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study; Low-dose aspirin, oral, as prescribed by physician through end of study
Intervention MeSH terms: Aspirin; Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACS

Summary:

      This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a
      medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute
      coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary
      revascularization).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index
             event within 10 days prior to randomization

          -  Had a medical management strategy decision made with reasonable certainty that neither
             percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is
             planned for treatment of the index event

          -  Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

        Key Exclusion Criteria:

          -  Decision for medical management greater than 72 hours after onset of index event
             without commercial clopidogrel treatment within 72 hours following onset of the index
             event.

          -  Insignificant coronary artery disease (CAD) on coronary angiography if performed for
             Index Event (absence of greater than or equal to 30% stenosis in at least one native
             vessel)

          -  Previous or planned PCI or CABG as treatment for the index event

          -  PCI/CABG within previous 30 days

          -  ST-segment elevation myocardial infarction (STEMI) as the index event

          -  Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association
             (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours

          -  History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA),
             Intracranial neoplasm, arteriovenous malformation, or aneurysm

          -  History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring
             hospitalization for treatment, unless definitive treatment has occurred and there is
             low likelihood of recurrence

          -  Hemodialysis or peritoneal dialysis