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.
調査の概要
状態
詳細な説明
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
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Amsterdam、オランダ
- 積極的、募集していない
- Onze Lieve Vrouwe Gasthuis
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Breda、オランダ
- 積極的、募集していない
- Amphia Ziekenhuis
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Nieuwegein、オランダ
- 募集
- St. Antonius Hospital
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コンタクト：
- Wilbert Bor, MD
- 電話番号：+31640907188
- メール：w.bor@antoniusziekenhuis.nl
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Tilburg、オランダ
- 積極的、募集していない
- Elizabeth-Tweesteden Ziekenhuis
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Aalst、ベルギー
- 積極的、募集していない
- Onze Lieve Vrouw Ziekenhuis
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Antwerpen、ベルギー
- 積極的、募集していない
- Universitair Ziekenhuis Antwerpen
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Bonheiden、ベルギー
- 募集
- Imelda Ziekenhuis
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Genk、ベルギー
- 募集
- Ziekenhuis Oost-Limburg
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Leuven、ベルギー
- 積極的、募集していない
- Universitair Ziekenhuis Leuven
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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].
時間枠：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].
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jurriën M ten Berg, MD, PhD、St. Antonius Hospital Nieuwegein, the Netherlands
- 主任研究者：Willem JM Dewilde, MD, PhD、Imelda Hospital Bonheiden, Belgium
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- R&D/Z14.016/WOEST2
- WOEST2-004 (その他の識別子：WOEST 2 Study Team)
- V.21483/W14.007 (その他の識別子：Medical research Ethics Committees United - St. Antonius Hospital, the Netherlands)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。