Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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 percutaneous coronary interventions (PCI). Many patients on dual antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in particular atrial fibrillation, therefore having an indication to also receive oral anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under "triple therapy" which consists of aspirin plus clopidogrel plus an oral anticoagulant. The ever raising population with CAD warranting triple therapy and the growing number of patients being treated with dabigatran underscores the importance of understanding the pharmacodynamic effects of this treatment regimen.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Dabigatran

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.