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

NCT00385138 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5364

Last updated 2014-05-05

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Simona Skerjanec, PharmD · The Medicines Company

  • Deepak L. Bhatt, MD · The Cleveland Clinic

  • Robert A. Harrington, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-05-31
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00385138 on ClinicalTrials.gov