Clinical trial NCT02635230: What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillations
Heart Valve Prostheses
Acute Coronary Syndromes
Coronary Artery Diseases
Stroke
Bleeding
Myocardial Infarction
Keywords: Atrial Fibrillations
Heart Valve Prostheses
Acute Coronary Syndromes
Percutaneous Coronary Revascularization
Coronary Artery Bypass Grafting
Coronary Artery Diseases
Myocardial Infarction
Ischemic stroke
Bleeding
Thrombosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Platelet Aggregation Inhibitors
Aspirin
Clopidogrel
Ticagrelor
Prasugrel
Antithrombotic treatment
Oral anticoagulation
Warfarin
Dabigatran etexilate mesylate
Apixaban
Rivaroxaban
Direct Factor Xa Inhibitors
Direct Thrombin Inhibitors
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
Collaborators: name: St. Antonius Hospital
First posted: 2015-12-18
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: WOEST2 Registry is designed to recruit an unselected cohort of patients with AF and/or a heart valve prosthesis undergoing coronary revascularisation (PCI/CABG) within at least three European countries (Netherlands, Belgium, United Kingdom). The three international cohorts of patients reflect the spectrum of our study population within the geographic catchment regions. At least 15 hospitals of varying size and characteristics will participate in this study.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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].
timeFrame: 1 year
measure: The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome].
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Tilburg
country: Netherlands
facility: Elizabeth-TweeSteden Ziekenhuis
Study officials:
affiliation: St. Antonius Hospital Nieuwegein, the Netherlands
name: Jurriën M ten Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imelda Hospital Bonheiden, Belgium
name: Willem JM Dewilde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: