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Aspirin-Free Strategy After 3-6 Month Dual Antiplatelet Therapy in Acute Coronary Syndrome

2026년 7월 29일 업데이트: Asmaa Sayed Shaban Ali, Assiut University

Aspirin-Free Strategy After 3-6 Month Dual Antiplatelet Therapy in Acute Coronary Syndrome Patients Who Underwent Complete Revascularization : A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the safety and efficacy of an aspirin-free strategy after 3-6 months of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) who have undergone complete coronary revascularization by percutaneous coronary intervention (PCI). Participants will be randomized to either discontinue aspirin and continue P2Y12 inhibitor monotherapy or continue standard antiplatelet therapy. The primary objective is to determine whether the aspirin-free strategy reduces bleeding events without increasing ischemic events during follow-up.

연구 개요

상세 설명

Acute Coronary Syndrome (ACS) remains a leading cause of cardiovascular mortality and morbidity worldwide. Current management of ACS-including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and high-risk unstable angina (UA)-relies on early invasive revascularization using Percutaneous Coronary Intervention (PCI) with contemporary Drug-Eluting Stents (DES). Following PCI, endothelial injury and stent implantation activate platelet aggregation and thrombosis, making Dual Antiplatelet Therapy (DAPT) with aspirin plus a P2Y12 inhibitor the standard treatment to prevent stent thrombosis and recurrent ischemic events. International guidelines have traditionally recommended 12 months of DAPT after ACS. However, prolonged DAPT increases the risk of bleeding, including gastrointestinal and intracranial hemorrhage, which is associated with higher mortality, treatment discontinuation, poor adherence, and increased healthcare utilization.

To improve the balance between ischemic protection and bleeding risk, several landmark randomized trials-including TWILIGHT, TICO, STOPDAPT-2, STOPDAPT-3, SMART-CHOICE, and GLOBAL LEADERS-have investigated abbreviated DAPT followed by P2Y12 inhibitor monotherapy after 1-3 months of treatment. These studies consistently demonstrated a significant reduction in major bleeding without a corresponding increase in major ischemic outcomes, including myocardial infarction or stent thrombosis.

Despite these promising findings, most available evidence has been generated in East Asian populations, where genetic factors, including CYP2C19 polymorphisms, and differences in thrombotic and bleeding risk may limit the generalizability of the results to other populations This clinical trial aims to address this important evidence gap by evaluating the safety and efficacy of abbreviated DAPT followed by P2Y12 inhibitor monotherapy in a non-Asian ACS population undergoing PCI with contemporary drug-eluting stents

연구 유형

중재적

등록 (추정된)

300

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Asyut Governorate
      • Asyut, Asyut Governorate, 이집트, 71515
        • Assiut University hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • 1. Must have an established, objectively confirmed diagnosis of an acute coronary syndrome, classified as STEMI, NSTEMI, or high-risk Unstable Angina.

    2. Underwent successful PCI with deployment of contemporary drug-eluting stents (DES) and TIMI 3 flow.

    3. Achieved documented complete revascularization of all angiographically significant lesions during the index procedure.

    4. Maintained absolute adherence to standard, uncomplicated combination DAPT for exactly 30 ± 7 days following the index PCI, remaining completely free of any ischemic or bleeding events during this initial month.

    5. Patient is fully coherent, cooperative, able to comply with the mandated multi-month follow-up schedule, and has provided independent, written, personally signed informed consent prior to randomization.

Exclusion Criteria:

Left Main (LM) Coronary Artery Disease & bifurcation lesions with 2 stents : Any angiographically documented significant stenosis (>50% diameter stenosis) involving the unprotected left main coronary artery trunk, regardless of whether it was treated with a stent during the index procedure or left untreated.

2. Incomplete Revascularization / Residual Target Lesions: Presence of any remaining untreated coronary lesion with >50% diameter stenosis in any major epicardial vessel or branch with a reference vessel diameter ≥2.0 mm that requires, or is planned to require, any future surgical or percutaneous revascularization within the next 12 months. This 'other lesion' exclusion ensures a fully revascularized cohort.

3. Any prior historical or documented acute, subacute, or late definitive stent thrombosis.

4. High baseline ischemic features including end-stage chronic kidney disease (eGFR < 30 mL/min/1.73m²), severe left ventricular dysfunction (LVEF < 30%), or an un-revascularized multi-vessel burden with high residual SYNTAX score (>22).

5. Definitive clinical indication for continuous, long-term oral anticoagulation therapy (e.g., atrial fibrillation, mechanical valves, deep vein thrombosis, or pulmonary embolism).

6. Active major pathological bleeding, history of any spontaneous or traumatic intracranial hemorrhage, vascular malformations of the central nervous system, or an established bleeding diathesis.

7. Active system-wide infections, or documented chronic systemic inflammatory or autoimmune disorders (such as severe active rheumatoid arthritis, systemic lupus erythematosus, polymyalgia rheumatica, active inflammatory bowel disease), or active malignancies, which confound baseline leukocyte values.

8. Known severe hypersensitivity, documented allergy, or major medical intolerance to acetylsalicylic acid (Aspirin) or clopidogrel (Plavix).

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공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Aspirin + clopidogrel
Aspirin will be discontinued after 3-6 months of dual antiplatelet therapy. Participants will continue P2Y12 inhibitor monotherapy (Clopidogrel 75 mg once daily or Ticagrelor 90 mg twice daily, according to the treating physician) for the remainder of the follow-up.
Aspirin will be discontinued after 3-6 months of dual antiplatelet therapy, and participants will continue P2Y12 inhibitor monotherapy for the remainder of the study follow-up
활성 비교기: Standered Antiplatelet Therapy (Aspirin + Clopidogrel)
Participants will continue standard antiplatelet therapy according to current guideline-directed management after complete coronary revascularization.
Participants will continue standard antiplatelet therapy according to current clinical practice after complete coronary revascularization.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Net adverse clinical events
기간: 12 months
Composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, ischemic stroke, or definite/probable stent thrombosis) and major bleeding (BARC type 3 or 5).
12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Major Adverse Cardiovascular Events (MACE)
기간: 12 months

Major Adverse Cardiac Events (MACE): A strict composite endpoint consisting of cardiovascular mortality, non-fatal myocardial infarction, or acute ischemic stroke.

  • Cardiovascular Mortality: Incorporates any death resulting from an acute myocardial infarction, sudden cardiac death, fatal cardiac arrest, cardiogenic shock, terminal heart failure, fatal stroke, or any death directly caused by a documented procedural complication related to the index or staged PCI.
  • Myocardial Infarction (MI): Diagnosed and classified in strict accordance with the Fourth Universal Definition of Myocardial Infarction (Type 1 spontaneous, Type 2 demand mismatch, Type 4a PCI-related).
  • Stent Thrombosis (ST): Formally categorized according to the Academic Research Consortium (ARC) consensus definitions into definite, probable, or possible stent thrombosis. Definite Stent Thrombosis requires unequivocal angiographic confirmation of a thrombus originating within or directly adjacent to the stented segment
12 months
Bleeding
기간: 12 months
The primary safety outcome is the occurrence of bleeding complications, which will be characterized using the international Bleeding Academic Research Consortium (BARC) consensus
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 15일

기본 완료 (추정된)

2029년 7월 30일

연구 완료 (추정된)

2030년 6월 1일

연구 등록 날짜

최초 제출

2026년 7월 25일

QC 기준을 충족하는 최초 제출

2026년 7월 29일

처음 게시됨 (실제)

2026년 7월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Aspirin-free strategy2542

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

There is no plan to share individual participant data.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

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. .

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