経皮的冠動脈インターベンション後の転帰を改善するための二重抗血小板療法のアルゴリズムベースの調整 (TAILOR-DAPT)
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.
調査の概要
状態
詳細な説明
Background:
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. European guidelines recommend to implement risk scores to guide the duration of DAPT after stent implantation (class IIb, level of evidence A). However, its adoption rate remains exceedingly low in daily clinical practice in part due to the lack of direct evidence obtained from a randomized controlled trial supporting this strategy.
Aim:
Using a pragmatic study-design, the investigators aim to determine the efficacy and safety of an algorithm-guided strategy for DAPT duration compared to a standard-of-care DAPT without the use of risk scores in patients undergoing PCI with stent implantation.
Methodology:
This investigator-initiated, single-blind, randomized trial will include a total of 2788 patients aged ≥18 years undergoing PCI with stent implantation. Main exclusion criteria are peri-procedural complications potentially affecting DAPT duration. The study will be nested into a well-running registry to minimize study-related costs (pragmatic trial approach). Patients will be randomized to an algorithm-guided DAPT group or a standard-of-care DAPT group in a 1:1 fashion. In the algorithm-guided group, DAPT duration will be determined according to the PRECISE-DAPT score (≥25 or <25) / Precise-HBR score (≥23 or <23), PCI complexity, and clinical presentation (acute or chronic coronary syndromes). In the standard-of-care DAPT group, treatment duration is at the operator's discretion. The primary endpoint is a composite of net adverse clinical events (NACE) defined as all-cause death, spontaneous myocardial infarction, stroke, definite stent thrombosis or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding at 1 year.
Potential significance:
This will be the first study evaluating the impact of a score-based decision-making algorithm integrating bleeding and ischemic risks for DAPT duration among patients undergoing PCI. The hypothesis is that the proposed simple decision-making algorithm minimizes bleeding risk and maximizes ischemic benefit compared to a standard-of-care DAPT regimen. Prospective data obtained from a pragmatic randomized controlled trial embedded into an on-going, well-managed PCI registry database may further enhance the adoption rate of such a strategy in clinical practice.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lorenz Räber, MD, PhD
- 電話番号：+41 31 632 09 29
- メール：Lorenz.raeber@insel.ch
研究連絡先のバックアップ
- 名前：Miklos Rohla, MD, PhD
- 電話番号：+41 31 632 21 11
- メール：miklos.rohla@insel.ch
研究場所
-
-
-
Roma、イタリア、00184
- 募集
- UOC Cardiologia San Giovanni Addolorata Hospital
-
コンタクト：
- Flavio Biccirè, Dr.
- メール：fbiccire@hsangiovanni.roma.it
-
-
-
-
-
Bern、スイス、3010
- 募集
- Department of Cardiology, Bern University Hospital
-
主任研究者：
- Miklos Rohla, MD, PhD
-
-
Canton of Bern
-
Biel/Bienne、Canton of Bern、スイス、2501
- 募集
- Kardiologie Spitalzentrum Biel
-
コンタクト：
- Roberto Galea, Dr. med.
- 電話番号：032 324 48 77
- メール：roberto.galea@szb-chb.ch
-
-
-
-
-
Banja Luka、ボスニア・ヘルツェゴビナ、78000
- 募集
- University Clinical Center of the Republic of Srpska
-
コンタクト：
- Bojan Stanetic, MD, PhD
- 電話番号：+387 51 342-100
- メール：bojan.stanetic@gmail.com
-
主任研究者：
- Bojan Stanetic, MD, PhD
-
-
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
説明
Inclusion Criteria:
- PCI with drug eluting stent (DES) implantation
- Age ≥18 years
- Ability to sign informed consent before any study-specific procedure
Exclusion Criteria:
- Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)
- Indication for oral anticoagulation
- Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)
- Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
- Active bleeding requiring medical attention at qualifying PCI
- The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
- Life expectancy less than 1 year
- Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
- Planned surgery within the next 3 months
- Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)
- Participation in a drug trial
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
Algorithm-guided DAPT duration |
PRECISE-DAPT score ≥25 / PRECISE-HBR Score ≥23
PRECISE-DAPT score <25 / PRECISE-HBR Score <23:
|
|
アクティブコンパレータ：Standard
Standard-of-care DAPT duration |
DAPT strategy at the operators´ discretion in accordance with applicable guidelines |
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 |
|---|---|---|
|
Net adverse clinical events (NACE)
時間枠：1 year
|
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or non-access site related BARC 2, 3 or 5 bleeding |
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
標的血管血行再建術
時間枠：1年
|
1年
|
|
|
確実なステント血栓症
時間枠：1年
|
1年
|
|
|
心筋梗塞
時間枠：1年
|
1年
|
|
|
血行再建術
時間枠：1年
|
1年
|
|
|
脳卒中
時間枠：1年
|
1年
|
|
|
標的病変の血行再建
時間枠：1年
|
1年
|
|
|
心血管死
時間枠：1年
|
1年
|
|
|
全死因
時間枠：1年
|
1年
|
|
|
標的血管心筋梗塞
時間枠：1年
|
1年
|
|
|
非標的血管血行再建術
時間枠：1年
|
1年
|
|
|
一過性脳虚血発作
時間枠：1年
|
1年
|
|
|
自然発生性心筋梗塞
時間枠：1年
|
1年
|
|
|
Major adverse cardiovascular events (MACE)
時間枠：1 year
|
Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke |
1 year
|
|
Major or clinically relevant non-major bleeding
時間枠：1 year
|
Non-access site related Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
1 year
|
|
Major bleeding
時間枠：1 year
|
Non-access site related Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding |
1 year
|
|
Any non-access site related Bleeding Academic Research Consortium (BARC) bleeding
時間枠：1 year
|
1 year
|
|
|
Target lesion failure
時間枠：1 year
|
Cardiac death, target-vessel myocardial infarction or target lesion revascularization |
1 year
|
|
Adherence to DAPT
時間枠：1 year
|
According to the TAILOR-DAPT modified Non-adherence Academic Research Consortium (NARC) classification |
1 year
|
|
Adherence to DAPT
時間枠：1 year
|
According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date) |
1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Net adverse clinical events (NACE)
時間枠：24 months
|
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
24 months
|
協力者と研究者
捜査官
- スタディチェア：Lorenz Räber, MD, PhD、Department of Cardiology, Bern University Hospital, Bern, Switzerland
- 主任研究者：Miklos Rohla, MD, PhD、Department of Cardiology, Bern University Hospital, Bern, Switzerland
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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。