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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5,364
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)
Innovis Health
Fargo, North Dakota, United States
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
mITT population; (composite incidence)
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality or MI
mITT population
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality
mITT population
Time frame: randomization through 48 hours post randomization
Incidence of MI
mITT population
Time frame: randomization through 48 hours post randomization
Incidence of IDR
mITT population
Time frame: randomization through 48 hours post randomization
Incidence of Stent Thrombosis
mITT population
Time frame: randomization through 48 hours post randomization
Incidence of Stroke
mITT
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality
mITT population
Time frame: randomization through 1 year post randomization
Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]
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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
mITT population A patient could have multiple procedural events.
Time frame: During index PCI
Incidence of GUSTO Severe / Life-threatening
Major bleeding (non-CABG-related) - Safety population
Time frame: randomization through 48 hours post randomization
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
Major bleeding (non-CABG-related) - Safety population
Time frame: randomization through 48 hours post randomization
Incidence of ACUITY Major Bleeding
Major bleeding (non-CABG-related) - Safety population
Time frame: randomization through 48 hours post randomization
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma \>/= 5 cm.
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality, MI, or IDR
mITT population
Time frame: randomization through 30 days post randomization
Incidence of All-cause Mortality or MI
mITT population
Time frame: randomization through 30 days post randomization
Incidence of All-cause Mortality
mITT population
Time frame: randomization through 30 days post randomization
Incidence of MI
mITT population
Time frame: randomization through 30 days post randomization
Incidence of IDR
mITT population
Time frame: randomization through 30 days post randomization
Incidence of Stent Thrombosis
mITT population
Time frame: randomization through 30 days post randomization
Incidence of Stroke
mITT population
Time frame: randomization through 30 days post randomization