NCT00305162

A Clinical Trial to Demonstrate the Efficacy of Cangrelor

A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,882 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myocardial Infarction (MI)
• Acute Coronary Syndromes (ACS)

Interventions

Type	Name	Description
DRUG	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).
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.
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)
DRUG	Placebo capsules - end of infusion	Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
DRUG	Placebo capsules - as soon as possible after randomization	Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-05-01
• Completion: 2010-06-01
• First posted: 2006-03-21
• Last updated: 2014-05-08
• Results posted: 2014-04-23

Locations

1 site across 1 country: United States