Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy
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|ClinicalTrials.gov Identifier: NCT01852162|
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Dabigatran Drug: Placebo||Not Applicable|
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. Although this combination therapy allows a reduction of atherothrombotic and thromboembolic events, patients on triple therapy are at an increased risk of bleeding complications.
Dabigatran, a synthetic, reversible direct thrombin inhibitor, has been studied as an alternative to warfarin in patients with atrial fibrillation and has been shown to be at least as efficacious with a favorable safety profile. In particular, dabigatran at a dose of 110 mg is associated with rates of stroke and systemic embolism similar to warfarin, with lower rates of major hemorrhage, while a dose of 150 mg is associated with lower thrombotic events with similar rates of bleeding events. These findings have led the Food and Drug Administration (FDA) to approve dabigatran for use in atrial fibrillation patients in December 2011 and this has also been implemented in practice guidelines to be a superior strategy to warfarin. However, the FDA only approved the 150mg formulation.
Dabigatran has high affinity and specificity for its target serine protease thrombin, and one small study shows that dabigatran produced potent inhibition of thrombin-induced platelet aggregation in vitro. However, there are no studies assessing the ex vivo pharmacodynamic effects of dabigatran in patients on dual antiplatelet therapy. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pharmacodynamic Effects of Dabigatran in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
Other Name: Pradaxa
Placebo Comparator: Placebo
Matching placebo tablets
- TRAP-induced Platelet Aggregation [ Time Frame: 1 week ]TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups
- Platelet Reactivity Measured by LTA [ Time Frame: 1-week ]Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).
- Platelet Reactivity Measured by Multiple Electrode Aggregometry. [ Time Frame: 1-week ]Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.
- Clot Kinetic: Thrombin Activity [ Time Frame: 1-week ]Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.
- Clot Kinetic: Clot Stength [ Time Frame: 1-week ]Clot strength (maximal amplitude:MA) was assessed by thromboelastography.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852162
|United States, Florida|
|University of Florida|
|Jacksonville, Florida, United States, 32209|
|Principal Investigator:||Dominick Angiolillo, MD, PhD||University of Florida|