What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.

Stroke Clinical Trial

— WOEST 2  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635230
• Other study ID #: R&D/Z14.016/WOEST2
• Secondary ID: WOEST2-004V.2148
• Status: Recruiting
• Start date: June 2014
• Est. completion date: January 2022

Study information

• Verified date: September 2019
• Source: R&D Cardiologie
• Contact: Wilbert Bor, MD
• Phone: +31640907188
• Email: w.bor[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Atrial Fibrillation
• Atrial Fibrillations
• Bleeding
• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Heart Valve Prostheses
• Hemorrhage
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Stroke

Intervention

Drug:
• Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
R&D Cardiologie	St. Antonius Hospital

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

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

External Links

•   Dewilde, WJ et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013 Mar 30;381(9872):1107-15.