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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00305162 |
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.
Two (2) separate sub-studies will be conducted at selected study sites:
Condition | Intervention | Phase |
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Unstable Angina Myocardial Infarction Acute Coronary Syndromes |
Drug: cangrelor (P2Y12 inhibitor) Drug: clopidogrel (P2Y12 inhibitor) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention. |
Estimated Enrollment: | 9000 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
placebo capsules (to match) + cangrelor bolus -(30 ug/kg) & infusion (4ug/kg/min)
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Drug: cangrelor (P2Y12 inhibitor)
Bolus (30 ug/kg) & infusion (4 ug/kg/min) administered within 30 minutes of the start of PCI - infusion to continue minimum of 2 hours and no longer than 4 hours.
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2: Active Comparator
clopidrogrel capsules (600 mg) + placebo bolus & infusion (to match)
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Drug: clopidogrel (P2Y12 inhibitor)
600 mg active clopidogrel given 30 minutes prior to the start of PCI.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
To be included in this study, subjects must meet the following criteria:
EXCLUSION CRITERIA
Subjects will be excluded from the study if they present with any of the following:
Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
Contact: Meredith Todd | 973-647-6088 | Meredith.Todd@themedco.com |
United States, Pennsylvania | |
Pennsylvania Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19107-6192 | |
Contact: Charles V. Pollack, Jr., M.D. 215-829-3264 |
Principal Investigator: | Deepak L. Bhatt, MD | The Cleveland Clinic |
Principal Investigator: | Robert A. Harrington, MD | Duke University Medical Center and Duke Clinical Research Institute |
Study Director: | Simona Skerjanec, PharmD | The Medicines Company |
Responsible Party: | The Medicines Company ( Simona Skerjanec, PharmD ) |
Study ID Numbers: | TMC-CAN-05-02 |
Study First Received: | March 17, 2006 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00305162 |
Health Authority: | United States: Food and Drug Administration |
Acute Coronary Syndrome PCI NStemi |
Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Ischemia Chest Pain |
Signs and Symptoms Necrosis Clopidogrel Acute Coronary Syndrome Infarction Myocardial Infarction Angina, Unstable |
Disease Pathologic Processes Therapeutic Uses Syndrome |
Hematologic Agents Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |