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临床试验/NCT05936606
NCT05936606招募中不适用

A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients: TAILOR-DAPT

Yonsei University1 个研究点 分布在 1 个国家目标入组 3,434 人开始时间: 2023年8月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
3,434
试验地点
1
主要终点
Net Clinical Adverse Clinical Events (NACE) for 24 months

研究概览

简要总结

Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent (DES) placement. However, concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR (high platelet reactivity) who do not respond adequately to clopidogrel. This study aims to evaluate the effectiveness of a patient-tailored antiplatelet therapy strategy that considers platelet aggregation in high-risk patients with DES placement beyond 12 months after stenting.

详细描述

This study will randomly assign eligible participants who underwent drug-eluting stent placement and have maintained the standard antiplatelet therapy for 12 months to either a control group or an intervention group. The control group will continue receiving clopidogrel monotherapy for 24 months regardless of their PRU (platelet reactivity unit) values. The intervention group will receive personalized antiplatelet therapy based on their PRU values: for non-HPR patients (PRU<208), clopidogrel monotherapy will be continued; for HPR patients (PRU≥208), dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation and individual patients' ischemic/bleeding risk profiles. Patients (≥50 years) who presented with acute myocardial infarction at the time of coronary intervention, and have high-risk characteristics (① ≥65 years ② multi-vessel disease ③ diabetes mellitus ④ chronic kidney disease ⑤ recurrent myocardial infarction) will receive ticagrelor 60 mg twice daily with aspirin, whereas the remainder will receive clopidogrel with aspirin. For high-bleeding-risk patients with two or more major bleeding risk factors according to ARC-HBR, the investigator may consider early discontinuation of dual antiplatelet therapy or de-escalation therapy like aspirin monotherapy based on the patient's risk profile. The treatment assignment ratio is 1:1. The study period will be up to 24 months from the time of randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years old
  • Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago.
  • At least one high risk characteristics of ischemic events
  • High risk patients
  • Acute coronary syndrome
  • Previous history of cerebrovascular accidents
  • Previous history of peripheral artery intervention
  • Heart failure
  • Diabetes mellitus requiring medication
  • Chronic kidney disease (regardless of requirement of renal replacement therapy)
  • High risk lesions
  • Left main disease
  • Multivessel disease, 2- or 3- vessels
  • Bifurcation lesions requiring 2 or more stents
  • Chronic total occlusion
  • In-stent restenosis
  • Graft lesions
  • Diffuse long lesion requiring stent(s) with total stent length ≥28 mm
  • Lesion at small sized vessel requiring stent(s) with stent diameter ≤2.5 mm
  • Calcified lesions requiring atherectomy

排除标准

  • Patients > 80 years old
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year
  • Refusal or inability to understand of informed consent
  • Patients eligible to long-term anticoagulation therapy
  • Patients with major bleeding events in previous 3 months before randomization

研究组 & 干预措施

Uniform Therapy

Active Comparator

Patients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement.

干预措施: Clopidogrel monotherapy (Drug)

Tailored Therapy

Experimental

Patients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk

干预措施: Tailored anti-platelet therapy (Drug)

结局指标

主要结局

Net Clinical Adverse Clinical Events (NACE) for 24 months

时间窗: upto 2 years after randomization

A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding

次要结局

  • Stent thrombosis(upto 2 years after randomization)
  • Stroke(upto 2 years after randomization)
  • All-cause death(upto 2 years after randomization)
  • Cardiovascular death(upto 2 years after randomization)
  • Any revascularization(upto 2 years after randomization)
  • Myocardial infarction(upto 2 years after randomization)
  • Bleeding Academic Research Consortium (BARC) type 5 bleeding(upto 2 years after randomization)
  • Ischemia-driven target vessel revascularization(upto 2 years after randomization)
  • Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding(upto 2 years after randomization)
  • Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding(upto 2 years after randomization)
  • Bleeding Academic Research Consortium (BARC) type 2 bleeding(upto 2 years after randomization)
  • All-cause death, myocardial infarction, or stroke(upto 2 years after randomization)
  • Cardiovascular death, myocardial infarction, stent thrombosis, or stroke(upto 2 years after randomization)
  • Bleeding Academic Research Consortium (BARC) type 3 bleeding(upto 2 years after randomization)
  • All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding(upto 2 years after randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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