Conditions: Atherosclerosis Acute Coronary Syndrome (ACS)
Keywords: Percutaneous Coronary Intervention (PCI) ACS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5364
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: cangrelor bolus (30 mcg/kg) \& 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 (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion arm 2: placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion

Interventions: intervention 1: Cangrelor intervention 2: clopidogrel intervention 3: Placebo bolus & placebo infusion intervention 4: Placebo capsules - end of PCI intervention 5: Placebo capsules - end of infusion
Intervention descriptions: intervention 1: 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) intervention 2: clopidogrel capsules (600 mg) at end of PCI intervention 3: 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) intervention 4: Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing intervention 5: Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Protocol document: