A Clinical Trial to Demonstrate the Efficacy of Cangrelor
Condition: Myocardial Infarction (MI); Acute Coronary Syndromes (ACS)
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Intervention: Cangrelor (P2Y12 inhibitor); clopidogrel (oral P2Y12 inhibitor); Placebo bolus & placebo infusion; Placebo capsules - end of infusion; Placebo capsules - as soon as possible after randomization
Intervention description: IV bolus (30 mcg/kg) & infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion).; 600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access.; placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion); Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing; Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing
Intervention MeSH terms: Clopidogrel; Cangrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8882.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndrome (ACS); Percutaneous Coronary Intervention (PCI); non-ST-segment elevation myocardial infarction (NSTEMI); ST-segment elevation myocardial infarction (STEMI)

Summary:

      The primary objective of this study is to demonstrate that the efficacy of cangrelor is
      superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
    

Eligibility criteria:

        INCLUSION CRITERIA

        To be included in this study, subjects must meet the following criteria:

          -  Angiography demonstrating atherosclerosis amenable to treatment by percutaneous
             coronary intervention (PCI) with or without stent implantation and diagnosis of Acute
             Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort
             w/electrocardiogram changes + age > 65 or diabetes or ST-elevation MI.

        EXCLUSION CRITERIA

        Subjects will be excluded from the study if they present with any of the following:

          1. Not a candidate for PCI

          2. Increased bleeding risk: ischemic stroke within the last year or any previous
             hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial
             aneurysm; recent (<1 month) trauma or major surgery (including by-pass surgery);
             currently receiving warfarin, active bleeding

          3. Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening;
             past or present bleeding disorder (including congenital bleeding disorders such as von
             Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained
             clinically significant bleeding disorders), thrombocytopenia (platelet count
             <100,000/µL), or history of thrombocytopenia or neutropenia associated with
             clopidogrel

          4. Severe hypertension not adequately controlled by antihypertensive therapy at the time
             of randomization

          5. Receipt of fibrinolytic therapy in the 12 hours preceding randomization

          6. Receipt of clopidogrel dose exceeding maintenance dose (ie, >75 mg) at any time in the
             5 days preceding randomization

          7. Inability to swallow study capsules

          8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable
             to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]

        Subjects excluded for any of the above reasons may be re-screened for participation at any
        time if the exclusion characteristic has changed.