Stroke Clinical Trial
— WOEST 2Official title:
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.
Status | Recruiting |
Enrollment | 2200 |
Est. completion date | January 2022 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria: 1. Patient is = 18 years of age; 2. Patients with a diagnosis of atrial fibrillation (prior to hospitalisation ór during hospitalisation within 72h after coronary revascularisation) and/or with a heart valve prosthesis (aortic/mitral); 3. Chronic treatment with OAC or NOAC therapy at inclusion or the intention to start chronic treatment with OAC or NOAC within 72h after coronary revascularisation AND with intended duration of treatment for at least one year after inclusion in the registry; 4. Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent); 5. Prescription of a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel) because of CABG following acute coronary syndrome* and /or because of PCI (with deployment of at least 1 coronary stent). 6. Patient has provided written informed consent. Exclusion Criteria: A potential subject who meets ANY of the following criteria will be excluded from participation in this study: 1. Patients unable to sign informed consent (including mental disabled patients); 2. Patients with life expectancy < 1 year; 3. Allergy or intolerance to P2Y12 inhibitors. |
Country | Name | City | State |
---|---|---|---|
Belgium | Onze Lieve Vrouw Ziekenhuis | Aalst | |
Belgium | Universitair Ziekenhuis Antwerpen | Antwerpen | |
Belgium | Imelda Ziekenhuis | Bonheiden | |
Belgium | Ziekenhuis Oost-Limburg | Genk | |
Belgium | Universitair Ziekenhuis Leuven | Leuven | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | St. Antonius Hospital | Nieuwegein | |
Netherlands | Elizabeth-TweeSteden Ziekenhuis | Tilburg |
Lead Sponsor | Collaborator |
---|---|
R&D Cardiologie | St. Antonius Hospital |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of the rate of non-fatal myocardial infarction, non-fatal ischemic stroke (including transient ischemic attack), non-central nervous system systemic embolization and cardiovascular death [the primary efficacy outcome]. | 1 year | ||
Primary | The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome]. | Bleeding will be classified by the Bleeding Academic Research Consortium (BARC) 2, 3, 4 and 5 bleeding criteria and by the Thrombolysis in Myocardial Infarction (TIMI) minor and major bleeding criteria. | 1 year |
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