A Clinical Trial to Demonstrate the Efficacy of Cangrelor

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

8882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Infarction (MI) Acute Coronary Syndromes (ACS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cangrelor

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

Group Type EXPERIMENTAL

Cangrelor (P2Y12 inhibitor)

Intervention Type DRUG

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).

clopidogrel (oral P2Y12 inhibitor)

Intervention Type DRUG

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.

Placebo capsules - as soon as possible after randomization

Intervention Type DRUG

Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing

Clopidogrel

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

Group Type ACTIVE_COMPARATOR

clopidogrel (oral P2Y12 inhibitor)

Intervention Type DRUG

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.

Placebo bolus & placebo infusion

Intervention Type DRUG

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 - end of infusion

Intervention Type DRUG

Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Interventions

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Cangrelor (P2Y12 inhibitor)

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).

Intervention Type DRUG

clopidogrel (oral P2Y12 inhibitor)

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.

Intervention Type DRUG

Placebo bolus & placebo infusion

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)

Intervention Type DRUG

Placebo capsules - end of infusion

Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Intervention Type DRUG

Placebo capsules - as soon as possible after randomization

Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing

Intervention Type DRUG

Other Intervention Names

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Plavix

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No