NCT00385138

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

A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention (PCI).

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,364 (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 (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).

Conditions

• Atherosclerosis
• Acute Coronary Syndrome (ACS)

Interventions

Type	Name	Description
DRUG	Cangrelor	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)
DRUG	clopidogrel	clopidogrel capsules (600 mg) at end of PCI
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 PCI	Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
DRUG	Placebo capsules - end of infusion	Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-05-01
• Completion: 2010-06-01
• First posted: 2006-10-06
• Last updated: 2014-05-05
• Results posted: 2014-04-21

Locations

1 site across 1 country: United States