A Clinical Trial to Demonstrate the Efficacy of Cangrelor (PCI)

The Medicines Company

Status and phase: Terminated; Phase 3

Conditions: Acute Coronary Syndromes (ACS); Myocardial Infarction (MI)

Treatments: Drug: Placebo capsules - end of infusion; Drug: Placebo capsules - as soon as possible after randomization; Drug: clopidogrel (oral P2Y12 inhibitor); Drug: Placebo bolus & placebo infusion; Drug: Cangrelor (P2Y12 inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00305162

TMC-CAN-05-02

Details and patient eligibility

About

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.

Enrollment: 8,882 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

To be included in this study, subjects must meet the following 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 or ST-elevation MI.

EXCLUSION CRITERIA

Subjects will be excluded from the study if they present with any of the following:

1. Not a candidate for PCI
2. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including by-pass surgery); currently receiving warfarin, active bleeding
3. 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), or history of thrombocytopenia or neutropenia associated with clopidogrel
4. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
5. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
6. Receipt of clopidogrel dose exceeding maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization
7. Inability to swallow study capsules
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]

Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8,882 participants in 2 patient groups

Cangrelor

Experimental group

Description:

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

Treatment:

Drug: clopidogrel (oral P2Y12 inhibitor)

Drug: Cangrelor (P2Y12 inhibitor)

Drug: Placebo capsules - as soon as possible after randomization

Clopidogrel

Active Comparator group

Description:

clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion

Treatment:

Drug: clopidogrel (oral P2Y12 inhibitor)

Drug: Placebo capsules - end of infusion

Drug: Placebo bolus & placebo infusion