- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635230
What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2. (WOEST 2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wilbert Bor, MD
- Phone Number: +31640907188
- Email: w.bor@antoniusziekenhuis.nl
Study Locations
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Aalst, Belgium
- Active, not recruiting
- Onze Lieve Vrouw Ziekenhuis
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Antwerpen, Belgium
- Active, not recruiting
- Universitair Ziekenhuis Antwerpen
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Bonheiden, Belgium
- Recruiting
- Imelda Ziekenhuis
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Genk, Belgium
- Recruiting
- Ziekenhuis Oost-Limburg
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Leuven, Belgium
- Active, not recruiting
- Universitair Ziekenhuis Leuven
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Amsterdam, Netherlands
- Active, not recruiting
- Onze Lieve Vrouwe Gasthuis
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Breda, Netherlands
- Active, not recruiting
- Amphia Ziekenhuis
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Nieuwegein, Netherlands
- Recruiting
- St. Antonius Hospital
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Contact:
- Wilbert Bor, MD
- Phone Number: +31640907188
- Email: w.bor@antoniusziekenhuis.nl
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Tilburg, Netherlands
- Active, not recruiting
- Elizabeth-TweeSteden Ziekenhuis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria:
- Patient is ≥ 18 years of age;
- 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);
- 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;
- Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent);
- 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).
- 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:
- Patients unable to sign informed consent (including mental disabled patients);
- Patients with life expectancy < 1 year;
- Allergy or intolerance to P2Y12 inhibitors.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with chronic oral anticoagulation and P2Y12 inhibitor
Patients with chronic indication for chronic oral anticoagulation (OAC) because of a heart valve prosthesis and/or atrial fibrillation undergoing coronary revascularisation (by PCI or CABG) and requiring concomitant treatment with P2Y12 inhibitors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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].
Time Frame: 1 year
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1 year
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The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome].
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jurriën M ten Berg, MD, PhD, St. Antonius Hospital Nieuwegein, the Netherlands
- Principal Investigator: Willem JM Dewilde, MD, PhD, Imelda Hospital Bonheiden, Belgium
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Ticagrelor
- Aspirin
- Rivaroxaban
- Cardiovascular Diseases
- Prasugrel
- Thrombosis
- Warfarin
- Bleeding
- Myocardial Infarction
- Platelet Aggregation Inhibitors
- Clopidogrel
- Apixaban
- Ischemic stroke
- Heart Diseases
- Oral anticoagulation
- Myocardial Ischemia
- Atrial Fibrillations
- Coronary Artery Bypass Grafting
- Embolism and Thrombosis
- Acute Coronary Syndromes
- Coronary Artery Diseases
- Antithrombotic treatment
- Percutaneous Coronary Revascularization
- Heart Valve Prostheses
- Dabigatran etexilate mesylate
- Direct Factor Xa Inhibitors
- Direct Thrombin Inhibitors
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Arrhythmias, Cardiac
- Myocardial Infarction
- Infarction
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Atrial Fibrillation
- Hemorrhage
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- R&D/Z14.016/WOEST2
- WOEST2-004 (Other Identifier: WOEST 2 Study Team)
- V.21483/W14.007 (Other Identifier: Medical research Ethics Committees United - St. Antonius Hospital, the Netherlands)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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