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.
연구 개요
상태
상세 설명
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
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드
- 모집하지 않고 적극적으로
- Onze Lieve Vrouwe Gasthuis
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Breda, 네덜란드
- 모집하지 않고 적극적으로
- Amphia Ziekenhuis
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Nieuwegein, 네덜란드
- 모병
- St. Antonius Hospital
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연락하다:
- Wilbert Bor, MD
- 전화번호: +31640907188
- 이메일: w.bor@antoniusziekenhuis.nl
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Tilburg, 네덜란드
- 모집하지 않고 적극적으로
- Elizabeth-Tweesteden Ziekenhuis
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Aalst, 벨기에
- 모집하지 않고 적극적으로
- Onze Lieve Vrouw Ziekenhuis
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Antwerpen, 벨기에
- 모집하지 않고 적극적으로
- Universitair Ziekenhuis Antwerpen
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Bonheiden, 벨기에
- 모병
- Imelda Ziekenhuis
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Genk, 벨기에
- 모병
- Ziekenhuis Oost-Limburg
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Leuven, 벨기에
- 모집하지 않고 적극적으로
- Universitair Ziekenhuis Leuven
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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].
기간: 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].
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jurriën M ten Berg, MD, PhD, St. Antonius Hospital Nieuwegein, the Netherlands
- 수석 연구원: Willem JM Dewilde, MD, PhD, Imelda Hospital Bonheiden, Belgium
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- R&D/Z14.016/WOEST2
- WOEST2-004 (기타 식별자: WOEST 2 Study Team)
- V.21483/W14.007 (기타 식별자: Medical research Ethics Committees United - St. Antonius Hospital, the Netherlands)
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