Conditions: Atherosclerosis Percutaneous Coronary Intervention Acute Coronary Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11145
Healthy volunteers: no

Brief summary:
The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

Detailed description:

Arms:
arm 1: Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered. arm 2: Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion.

During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.

Interventions: intervention 1: cangrelor P2Y12 (platelet) inhibitor intervention 2: Clopidogrel - 300 or 600 mg (study arm) intervention 3: Clopidogrel 600 mg post cangrelor
Intervention descriptions: intervention 1: None intervention 2: Over encapsulated tablets. intervention 3: over-encapsulated clopidogrel (600 mg)

Protocol document: