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A Clinical Trial to Demonstrate the Efficacy of Cangrelor

NCT00305162 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8882

Last updated 2014-05-08

Study results available
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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

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

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Deepak L. Bhatt, MD · The Cleveland Clinic

  • Robert A. Harrington, MD · Duke University Medical Center and Duke Clinical Research Institute

  • Simona Skerjanec, PharmD · The Medicines Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-05-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00305162 on ClinicalTrials.gov