Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.
Condition: Atherosclerosis; Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome; Atherosclerosis
Intervention: Cangrelor; clopidogrel; Placebo bolus & placebo infusion; Placebo capsules - end of PCI; Placebo capsules - end of infusion
Intervention description: cangrelor bolus (30 mcg/kg) & cangrelor 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); clopidogrel capsules (600 mg) at end of PCI; 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 PCI to mimic 600mg clopidogrel dosing; Placebo capsules given at the end of infusion 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: 5364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Percutaneous Coronary Intervention (PCI); ACS

Summary:

      The primary objective of this study is to demonstrate that the efficacy of cangrelor
      (combined with usual care) is superior to that of usual care, in subjects requiring
      percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality,
      myocardial infarction (MI), and ischemia-driven revascularization (IDR).
    

Eligibility criteria:

        Inclusion 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.

        Exclusion Criteria:

          1. Not a candidate for PCI

          2. ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization

          3. Increased bleeding risk: ischemic stroke within the last year or any previous
             hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or
             intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary
             artery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding

          4. 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) at screening

          5. Severe hypertension not adequately controlled by antihypertensive therapy at the time
             of randomization

          6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization

          7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding
             randomization

          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]