Conditions: Myocardial Infarction (MI) Acute Coronary Syndromes (ACS)
Keywords: Acute Coronary Syndrome (ACS) Percutaneous Coronary Intervention (PCI) non-ST-segment elevation myocardial infarction (NSTEMI) ST-segment elevation myocardial infarction (STEMI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8882
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: placebo capsules (to match) + 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) + active clopidogrel (600mg) post infusion arm 2: clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion

Interventions: intervention 1: Cangrelor (P2Y12 inhibitor) intervention 2: clopidogrel (oral P2Y12 inhibitor) intervention 3: Placebo bolus & placebo infusion intervention 4: Placebo capsules - end of infusion intervention 5: Placebo capsules - as soon as possible after randomization
Intervention descriptions: intervention 1: 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). intervention 2: 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. 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 infusion to mimic 600mg clopidogrel dosing intervention 5: Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing

Protocol document: