NCT03465644已完成4 期
Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention
Duk-Woo Park, MD22 个研究点 分布在 1 个国家目标入组 2,018 人开始时间: 2019年2月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,018
- 试验地点
- 22
- 主要终点
- Net clinical outcome
研究概览
简要总结
This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 and more
- •Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
- •Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;
- •Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or
- •Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm
- •The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
排除标准
- •Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
- •Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
- •Use of Gp IIb/IIIa inhibitors at randomization
- •Cardiogenic shock
- •Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
- •Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
- •Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
- •History of intracranial hemorrhage or intracranial aneurysm
- •Planned surgery within 180 days
- •Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
- •Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL
- •At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
- •Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment
- •: ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital
- •Pregnant and/or lactating women.
- •Concurrent medical condition with a life expectancy of less than 1 years
- •Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
- •Inability to provide written informed consent or participate in long-term follow-up
研究组 & 干预措施
Tailored arm
Experimental
early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy
干预措施: Tailored antithrombotic strategy (Drug)
Conventional arm
Active Comparator
clopidogrel + aspirin for 12months
干预措施: Conventional antithrombotic strategy (Drug)
结局指标
主要结局
Net clinical outcome
时间窗: 1 year
a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\] at 12 months after randomisation
次要结局
- Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)(1 year)
- Death(1 year)
- Myocardial infarction(1 year)
- Stroke(1 year)
- Stent thrombosis(1 year)
- Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)(1 year)
- BARC major bleeding (type 3 or 5 bleeding)(1 year)
- TIMI major or minor bleeding(1 year)
- The rate of unplanned urgent repeat revascularization(1 year)
- GUSTO moderate or severe bleeding(1 year)
- ISTH major bleeding(1 year)
- Any major or minor bleeding(1 year)
研究者
Duk-Woo Park, MD
Professor, Division of Cardiology
Asan Medical Center
研究点 (22)
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