Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition. (Platform)

The Medicines Company

Status and phase: Terminated; Phase 3

Conditions: Acute Coronary Syndrome (ACS); Atherosclerosis

Treatments: Drug: Placebo capsules - end of infusion; Drug: Placebo bolus & placebo infusion; Drug: clopidogrel; Drug: Cangrelor; Drug: Placebo capsules - end of PCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385138

TMC-CAN-05-03

Details and patient eligibility

About

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).

Enrollment: 5,364 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age > 65 or diabetes.

Exclusion criteria

1. Not a candidate for PCI
2. ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
3. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary artery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding
4. Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening
5. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5,364 participants in 2 patient groups

Cangrelor

Experimental group

Description:

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

Treatment:

Drug: Cangrelor

Drug: Placebo capsules - end of PCI

Drug: clopidogrel

Clopidogrel

Active Comparator group

Description:

placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion

Treatment:

Drug: Placebo bolus & placebo infusion

Drug: Placebo capsules - end of infusion

Drug: clopidogrel