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An International Prospective Registry on Concomitant Use of Oral Anticoagulants and P2Y12 Inhibitors in Patients With Atrial Fibrillation or Heart Valve Prosthesis Undergoing Coronary Revascularisation.
The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients current North American and European guidelines recommend a triple therapy strategy, including vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this triple therapy strategy is a significant increase in the risk of major bleeding. Furthermore, the ommitance of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K oral anticoagulants (NOAC), created numerous new antithrombotic treatment strategies for these patients with overlapping conditions. To date, evidence on the risks and benefits of these new antithrombotic treatment strategies is lacking. The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve prosthesis ánd undergoing coronary revascularisation through a better understanding of their demographics, antithrombotic management and related in-hospital and long-term outcomes. The WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment patterns and patient outcomes. Objective: To assess the different management patterns and related in-hospital and long-term safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12 inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation.
The WOEST 2 Registry is a prospective, international, multi-centre, non-interventional, cohort study designed to recruit an unselected cohort of patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation. Trial overview Name : WOEST 2 REGISTRY Target for enrollment : 2200 patients Time frame for inclusion : within 72 hours after index PCI or coronary artery bypass grafting (CABG) Follow-up : 24 months Visits : 30 days, 12 and 24 months after index PCI or CABG
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Elizabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
Start Date
June 1, 2014
Primary Completion Date
January 1, 2021
Completion Date
January 1, 2022
Last Updated
March 11, 2020
2,200
ESTIMATED participants
Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
DRUG
Lead Sponsor
R&D Cardiologie
Collaborators
NCT07429227
NCT07107971
Data Source & Attribution
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