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Cangrelor to Clopidogrel or Prasugrel Transition Study

Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Cangrelor (Drug); Clopidogrel (Drug); Prasugrel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
David J. Schneider, MD, Principal Investigator, Affiliation: University of Vermont Medical Center

Summary

There are two separate objectives in this study: 1. to demonstrate the pharmacodynamic profile when patients treated with cangrelor are switched to oral prasugrel administered 30 min after cangrelor infusion is discontinued and 2. to demonstrate the pharmacodynamic profile when patients treated with cangrelor are switched to clopidogrel 600mg administered during or immediately after the infusion.

Clinical Details

Official title: A Study of the Transition From Cangrelor to Clopidogrel or Prasugrel in Patients With Coronary Artery Disease.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Extent to which inhibitory effect of the oral thienopyridine is preserved at least 50% as measured by LTA.

Secondary outcome: Extent to which inhibitory effect of the oral thienopyridine is preserved at least 50% as measured by PRU, VerifyNow® P2Y12 assay

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Greater than / equal to 18 and less than 75 years of age, of either sex, and of any race. 2. Stable coronary artery disease defined by the following criteria: 1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q-waves on at least 2 contiguous electrocardiogram (ECG) leads. OR 2. Previous revascularization by PCI or CABG, and 3. Treatment with ASA 81 mg daily. Exclusion Criteria: 1. Known intolerance or contraindication to cangrelor or prasugrel, or any ingredients of the respective formulation. 2. Any antiplatelet (other than aspirin) or anticoagulant medication with the previous 30 days. 3. Acute coronary syndrome within the previous 12 months. 4. History of bleeding diathesis or known coagulopathy such as; impaired hemostasis: known international normalized ratio (INR) >1. 5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia), acquired bleeding disorders, and unexplained clinically significant bleeding disorders; thrombocytopenia (platelet count less than 100,000/µL), or history of thrombocytopenia or neutropenia associated with clopidogrel. 5. Anemia (ie, hematocrit less than 35%). 6. Prior stroke (any type), prior cerebral anteriovenous malformation or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery). 7. Known or suspected pregnancy, or lactating females. 8. Known severe renal insufficiency (glomerular filtration rate [GFR] less than 30 mL/min). 9. Inability to provide informed consent. 10. Moderate or severe hepatic impairment as per investigator discretion (elevation of liver function tests [LFTs]). 11. Inability to swallow oral medication at time of randomization. 12. Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, or metabolic disease. 13. Any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug (if applicable). 14. Treatment with other investigational medicinal products or devices within 30 days or 5 half-lives, whichever is longer, prior to the administration of the drug, or planned use of investigational medicinal products or devices. 15. Subjects who, for any reason, are deemed by the Investigator to be inappropriate for this study, including subjects who are unable to communicate or to cooperate with the Investigator. 16. Subject is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. 17. Active pathological bleeding, or a history of transient ischemic attack.

Locations and Contacts

Fletcher Allen Health Care, Burlington, Vermont 05401, United States
Additional Information

Starting date: November 2013
Last updated: March 26, 2014

Page last updated: August 23, 2015

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