Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Prasugrel; Clopidogrel; Placebo
Intervention description: Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.; Loading dose administered once orally.; Loading dose administered once orally
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Plavix, Effient

Summary:

      This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during
      percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on
      platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet
      inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in
      a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg).
      Understanding the effects of this combination on platelet inhibition will provide guidance to
      physicians on the use of prasugrel in patients who have already been pretreated with
      clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants hospitalized with acute coronary syndrome (ACS) [unstable angina (UA),
             non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction
             (STEMI)] as determined by the investigator, and who are anticipated to undergo
             percutaneous coronary intervention (PCI) as a treatment for the ACS event within 24
             hours of the clopidogrel/placebo loading dose

          -  Participants provide signed informed consent form (ICF)

          -  Participants weigh at least 60 kilograms (kg) at the time of screening

          -  Women of child-bearing potential (that is, women who are not surgically or chemically
             sterilized and who are between menarche and 1-year postmenopause), test negative for
             pregnancy at the time of enrollment based on a urine or serum pregnancy test

        Exclusion Criteria:

          -  Have cardiogenic shock at the time of randomization (systolic blood pressure greater
             than 90 millimeters of mercury (mm Hg) associated with clinical evidence of end-organ
             hypoperfusion, or participants requiring vasopressors to maintain systolic blood
             pressure over 90 mm Hg and associated with clinical evidence of end-organ
             hypoperfusion

          -  Have refractory ventricular arrhythmias

          -  Have New York Heart Association (NYHA) Class IV congestive heart failure

          -  Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure
             greater than 100 mm Hg on more than 1 assessment at any time from participant
             presentation of ACS treatment to enrollment

          -  Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to
             randomization

          -  Have received nonfibrin-specific fibrinolytic therapy less than 48 hours prior to
             randomization

          -  Have active internal bleeding or history of bleeding diathesis

          -  Have clinical findings, in the judgment of the investigator, associated with an
             increased risk of bleeding

          -  Prior history of ischemic or hemorrhagic stroke

          -  Intracranial neoplasm, arteriovenous malformation, or aneurysm

          -  Prior history of transient ischemic attack (TIA)

          -  Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time
             of evaluation

          -  Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of
             evaluation

          -  Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of
             evaluation

          -  Have received 1 or more doses of a thienopyridine (ticlopidine, clopidogrel, or
             prasugrel) or other adenosine diphosphate (ADP) receptor inhibitor within 10 days
             prior to screening

          -  Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7
             days or planned use of a GPIIb/IIIa inhibitor during PCI

          -  Are receiving or will receive oral anticoagulation or other antiplatelet therapy,
             other than aspirin (ASA), which cannot be safely discontinued for the duration of the
             study.

          -  Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or
             cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational drug or device or off-label use of a drug or
             device, or concurrently enrolled in any other type of medical research judged not to
             be scientifically or medically compatible with this study

          -  Have previously completed or withdrawn from this study or any other study
             investigating prasugrel

          -  Are women who are known to be pregnant, who have given birth within the past 90 days,
             or who are breastfeeding

          -  Have a concomitant medical illness (for example, terminal malignancy) that in the
             opinion of the investigator, is associated with reduced survival over the expected
             treatment period

          -  Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)

          -  Have a history of intolerance or allergy to aspirin or approved thienopyridines
             (ticlopidine, clopidogrel or prasugrel)

          -  May be unable to cooperate with protocol requirements and follow-up procedures