Clinical trial NCT01115738 (phase 2, status: completed)
Conditions: acute coronary syndrome
ICD codes: I24.0
Drugs: prasugrel, clopidogrel, placebo
SMILES: CC(=O)OC1=CC2=C(CCN(C2)C(C(=O)C2CC2)C2=CC=CC=C2F)S1, N[C@@H](CCCNC(N)=N)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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