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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8,882
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.
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
(composite incidence)
Time frame: randomization through 48 hours after randomization
Incidence of All-cause Mortality and MI
(composite incidence)
Time frame: randomization through 48 hours after randomization
Individual Incidence of All-cause Mortality
Time frame: randomization through 48 hours after randomization
Individual Incidence of IDR
Time frame: randomization through 48 hours after randomization
Incidence of Stroke
Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as: * primary hemorrhagic - stroke with focal collections of intracranial blood * ischemic cerebral infarction - stroke without focal collections of intracranial blood * infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding * uncertain - no imaging or autopsy data are available.
Time frame: randomization through 48 hours after randomization
Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI
(a patient could have multiple procedural events)
Time frame: during index PCI
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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
Incidence of All-cause Mortality, MI or IDR
(composite incidence)
Time frame: randomization through 30 days after randomization
Incidence of All-cause Mortality or MI
(composite incidence)
Time frame: randomization through 30 days after randomization
Incidence of All-cause Mortality
Time frame: randomization through 30 days after randomization
Incidence of MI
Time frame: randomization through 30 days after randomization
Incidence of IDR
Time frame: randomization through 30 days after randomization
Incidence of Stroke
Time frame: randomization through 30 days after randomization
Incidence of All Cause Mortality
(excluding STEMI)
Time frame: randomization through 1 year after randomization
Incidence of GUSTO Severe / Life-threatening Bleeding
Major bleeding (non-CABG-related) - Safety population
Time frame: randomization through 48 hours after randomization
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Major bleeding (non-CABG-related) - Safety population
Time frame: randomization through 48 hours after randomization
Incidence of ACUITY Major Bleeding
Major bleeding (non-CABG-related) - Safety population
Time frame: randomization through 48 hours after randomization
Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)
excludes ACUITY major bleeding for which the only qualifying event was hematoma \>/= 5 cm
Time frame: randomization through 48 hours after randomization