Status:
COMPLETED
Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy
Lead Sponsor:
University of Florida
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of atherothrombotic events in patients with coronary artery disease (CAD) undergoing perc...
Detailed Description
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of atherothrombotic events in patients with coronary artery disease (CAD) undergoing perc...
Eligibility Criteria
Inclusion
- Patients with known CAD
- On maintenance treatment with aspirin (81 to 325mg per day) and clopidogrel (75 mg per day) for at least for at least 4-weeks as per standard of care.
- Age between 18 and 80 years old.
Exclusion
- Transient ischemic attack or ischemic stroke in the past 6 months.
- Prior hemorrhagic stroke (irrespective of timing).
- Known allergies to dabigatran.
- On treatment with Coumadin derivate or have an indication to be on Coumadin treatment (atrial fibrillation, prosthetic valve, DVT/pulmonary embolism).
- Platelet count \<80x106/mL
- Active bleeding or hemodynamic instability.
- Creatinine clearance \<30 mL/minute.
- Baseline ALT \>2.5 times the upper limit of normal.
- Hemoglobin \< 10 gm/dL
- Pregnant females\*. \*Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01852162
Start Date
February 1 2012
End Date
February 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209