Status:
COMPLETED
A Pharmacodynamic Study With Ticagrelor in African American Patients
Lead Sponsor:
AstraZeneca
Conditions:
Stable Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.
Detailed Description
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in African American Patients with Stable Coronary Artery Disease
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent before initiation of any study-related procedures
- Male or female patients aged 18 years or older
- Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
- Females must be post menopausal or surgically sterile Self-identified as African American
Exclusion
- Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
- Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
- Current smokers, including the use of tobacco containing products in the past 1 month of randomization Patients required dialysis
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01523392
Start Date
March 1 2012
End Date
September 1 2013
Last Update
October 8 2014
Active Locations (8)
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1
Research Site
Newark, Delaware, United States
2
Research Site
Wilmington, Delaware, United States
3
Research Site
Washington D.C., District of Columbia, United States
4
Research Site
Hollywood, Florida, United States