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

R&D Cardiologie

Status: Unknown

Conditions: Coronary Artery Diseases; Stroke; Acute Coronary Syndromes; Atrial Fibrillations; Myocardial Infarction; Bleeding; Heart Valve Prostheses

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

Study type: Observational

Funder types: Other

Identifiers

NCT02635230

R&D/Z14.016/WOEST2

WOEST2-004 (Other Identifier)

V.21483/W14.007 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,200 participants in 1 patient group

Patients with chronic oral anticoagulation and P2Y12 inhibitor

Description:

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.

Treatment:

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