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

NCT02635230 | Unknown

• 3 other identifiers: R&D/Z14.016/WOEST2WOEST2-004V.21483/W14.007
• Study Type: observational
• Target: 2,200
• Locations: 2 countries
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

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

Interventions

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

Patients with chronic oral anticoagulation and P2Y12 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• R&D Cardiologie: lead
• St. Antonius Hospital: collaborator

Study Sites (9)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

ACTIVE NOT RECRUITING

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

ACTIVE NOT RECRUITING

Imelda Ziekenhuis

Bonheiden, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, Belgium

RECRUITING

Universitair Ziekenhuis Leuven

Leuven, Belgium

ACTIVE NOT RECRUITING

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

ACTIVE NOT RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

ACTIVE NOT RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Elizabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Acute Coronary Syndrome; Coronary Artery Disease; Stroke; Hemorrhage; Myocardial Infarction; Ischemic Stroke; Thrombosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jurriën M ten Berg, MD, PhD

  St. Antonius Hospital Nieuwegein, the Netherlands

  PRINCIPAL INVESTIGATOR

• Willem JM Dewilde, MD, PhD

  Imelda Hospital Bonheiden, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilbert Bor, MD

CONTACT

+31640907188; w.bor@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 18, 2015
• Study Start: June 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 11, 2020

Record last verified: 2019-09

Locations

NL (4); BE (5)