Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Primary ischemic endpoint
研究概览
简要总结
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy using a potent P2Y12-inhibitor such as prasugrel or ticagrelor.
Objective: This study will serve as a pilot to investigate the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to, during and after stent implantation in 75 patients with non-ST segment elevation acute coronary syndrome.
Study design: Single-center, single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis.
Study population: Patients presenting with non-ST segment elevation acute coronary syndrome and (a) 'de novo' lesion(s) treated with new generation drug-eluting stent(s) with adequate reduction of platelet reactivity according to platelet function testing with VerifyNow and optimal stenting result adjudicated by optical coherence tomography or coronary angiography.
Intervention: Once daily 10 mg prasugrel or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.
Main study endpoint: The primary ischemic endpoints is the composite of all-cause mortality, myocardial infarction, Academic Research Consortium defined stent thrombosis and ischemic stroke at 6 months after percutaneous coronary intervention. The primary bleeding outcome is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 6 months after percutaneous coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSTE-ACS diagnosis
- •'De novo' coronary lesion(s) eligible for PCI
- •Written informed consent
排除标准
- •Known allergy or contraindication for prasugrel and ticagrelor use.
- •Concurrent use of oral anticoagulants
- •Overwriting indication for DAPT
- •Planned surgical intervention within 12 months of planned revascularization
- •PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions
- •Recent or ongoing strong CYP3A4 inhibitor or inducer therapy
- •Recent or ongoing therapy with CYP4A4-substrates with a narrow therapeutic index
- •Pregnant or breastfeeding women at time of enrolment
- •Participation in another trial with an investigational drug or device (i.e. stent)
研究组 & 干预措施
Prasugrel or ticagrelor monotherapy
Once daily 10 mg prasugrel or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.
干预措施: Prasugrel 10mg (Drug)
Prasugrel or ticagrelor monotherapy
Once daily 10 mg prasugrel or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.
干预措施: Ticagrelor 90mg (Drug)
结局指标
主要结局
Primary ischemic endpoint
时间窗: 6 months
Number of participants with primary ischemic endpoint defined as composite of all-cause mortality, myocardial infarction, Academic Research Consortium defined stent thrombosis and ischemic stroke
Primary bleeding endpoint
时间窗: 6 months
Number of participants with primary bleeding endpoint defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding
次要结局
未报告次要终点
研究者
J.P.S Henriques
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)