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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Clopidogrel or ticagrelor alongside dabigatran in acute coronary syndrome and indication for NOAC: a study rationale
Jasper Luijkx1, Patty Winkler1,2, Arnoud van 't Hof1,2
1Department of Cardiology, Zuyderland Medical Center, 6419 PC Heerlen, The Netherlands.
Insights
This study compares dabigatran plus ticagrelor against dabigatran plus clopidogrel in patients with acute coronary syndrome after percutaneous coronary intervention. The goal is to assess if ticagrelor is non-inferior to clopidogrel regarding major bleeding events.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Patients with coronary stenting and atrial fibrillation often require dual therapy with oral anticoagulants and antiplatelet agents.
- Current standard care for acute coronary syndrome (ACS) post-percutaneous coronary intervention (PCI) involves clopidogrel plus a non-vitamin K antagonist oral anticoagulant (NOAC), omitting aspirin.
- Genetic variations affecting clopidogrel metabolism and high thromboembolic risk necessitate exploring alternative P2Y12 inhibitors.
Purpose of the Study:
- To evaluate the non-inferiority of dabigatran combined with ticagrelor compared to dabigatran combined with clopidogrel.
- To assess the primary endpoint of major bleeding in patients undergoing PCI for ACS while on chronic anticoagulation.
Main Methods:
- Prospective, multicenter, open-label, registry-based, randomized controlled trial.
- Inclusion of patients on chronic anticoagulants undergoing PCI for ACS.
- Comparison of dabigatran plus ticagrelor versus dabigatran plus clopidogrel.
- Primary endpoint defined by the Bleeding Academic Research Consortium (BARC) bleeding definition.
Main Results:
- N/A
Conclusions:
- N/A
Abstract:
The combination of oral anticoagulants with platelet inhibitors has been widely investigated in patients with coronary stenting and concomitant atrial fibrillation. In these patients, default therapy after percutaneous coronary intervention in acute coronary syndrome is clopidogrel plus non-vitamin K antagonist oral anticoagulant, omitting aspirin. However, in view of the high thromboembolic risk associated with acute coronary syndrome and the number of poor metabolizers for clopidogrel, investigation of alternative P2Y12-inhibitors is mandatory. This prospective, multicenter, open-label, registry-based, randomized, controlled trial aims to show the non-inferiority of dabigatran plus ticagrelor versus dabigatran plus clopidogrel in patients on chronic anticoagulants who undergo percutaneous coronary intervention in acute coronary syndrome. The primary end point is major bleeding as defined by the Bleeding Academic Research Consortium bleeding definition. Trial registration number: NL75644.096.21.
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