Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01852162
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2013-05-08
Brief Title:
Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacodynamic Effects of Dabigatran in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None