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

2026年7月29日 更新者: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.

研究概览

详细说明

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

研究类型

介入性

注册 (估计的)

300

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Asyut Governorate
      • Asyut、Asyut Governorate、埃及、71515
        • Assiut University hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

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).

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Net adverse clinical events
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Major Adverse Cardiovascular Events (MACE)
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月15日

初级完成 (估计的)

2029年7月30日

研究完成 (估计的)

2030年6月1日

研究注册日期

首次提交

2026年7月25日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Aspirin-free strategy2542

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

There is no plan to share individual participant data.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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