경피적 관상동맥 중재술 후 결과를 개선하기 위한 이중 항혈소판 요법의 알고리즘 기반 조정 (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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lorenz Räber, MD, PhD
- 전화번호: +41 31 632 09 29
- 이메일: Lorenz.raeber@insel.ch
연구 연락처 백업
- 이름: Miklos Rohla, MD, PhD
- 전화번호: +41 31 632 21 11
- 이메일: miklos.rohla@insel.ch
연구 장소
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Banja Luka, 보스니아 헤르체고비나, 78000
- 모병
- University Clinical Center of the Republic of Srpska
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연락하다:
- Bojan Stanetic, MD, PhD
- 전화번호: +387 51 342-100
- 이메일: bojan.stanetic@gmail.com
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수석 연구원:
- Bojan Stanetic, MD, PhD
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Bern, 스위스, 3010
- 모병
- Department of Cardiology, Bern University Hospital
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수석 연구원:
- Miklos Rohla, MD, PhD
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Canton of Bern
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Biel/Bienne, Canton of Bern, 스위스, 2501
- 모병
- Kardiologie Spitalzentrum Biel
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연락하다:
- Roberto Galea, Dr. med.
- 전화번호: 032 324 48 77
- 이메일: roberto.galea@szb-chb.ch
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Roma, 이탈리아, 00184
- 모병
- UOC Cardiologia San Giovanni Addolorata Hospital
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연락하다:
- Flavio Biccirè, Dr.
- 이메일: fbiccire@hsangiovanni.roma.it
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention
Algorithm-guided DAPT duration |
PRECISE-DAPT score ≥25 / PRECISE-HBR Score ≥23
PRECISE-DAPT score <25 / PRECISE-HBR Score <23:
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활성 비교기: Standard
Standard-of-care DAPT duration |
DAPT strategy at the operators´ discretion in accordance with applicable guidelines |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Net adverse clinical events (NACE)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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표적 혈관 재생술
기간: 일년
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일년
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명확한 스텐트 혈전증
기간: 일년
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일년
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심근 경색증
기간: 일년
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일년
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모든 혈관재생술
기간: 일년
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일년
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뇌졸중
기간: 일년
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일년
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표적 병변 재관류술
기간: 일년
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일년
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심혈관 사망
기간: 일년
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일년
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모든 원인의 죽음
기간: 일년
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일년
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표적 혈관 심근 경색
기간: 일년
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일년
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비표적 혈관재생술
기간: 일년
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일년
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일시적 허혈 발작
기간: 일년
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일년
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자발성 심근경색
기간: 일년
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일년
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Major adverse cardiovascular events (MACE)
기간: 1 year
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Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke |
1 year
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Major or clinically relevant non-major bleeding
기간: 1 year
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Non-access site related Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
1 year
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Major bleeding
기간: 1 year
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Non-access site related Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding |
1 year
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Any non-access site related Bleeding Academic Research Consortium (BARC) bleeding
기간: 1 year
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1 year
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Target lesion failure
기간: 1 year
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Cardiac death, target-vessel myocardial infarction or target lesion revascularization |
1 year
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Adherence to DAPT
기간: 1 year
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According to the TAILOR-DAPT modified Non-adherence Academic Research Consortium (NARC) classification |
1 year
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Adherence to DAPT
기간: 1 year
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According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date) |
1 year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Net adverse clinical events (NACE)
기간: 24 months
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All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
24 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Lorenz Räber, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland
- 수석 연구원: Miklos Rohla, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .