A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Effect of Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,020
- 试验地点
- 1
- 主要终点
- Major cardiovascular and cerebrovascular adverse events
研究概览
简要总结
The study is to evaluate the effect of optimized 12-month step-down antiplatelet therapy (APT) compared with standard 12-month dual antiplatelet therapy in clinical net adverse events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome (ACS) who are not the predominant coronary artery disease after percutaneous coronary intervention (PCI).
详细描述
This is a prospective, multi- center, randomized, parallel-group trial designed to evaluate the effect of optimized 12-month step-down antiplatelet therapy compared with standard 12-month dual antiplatelet therapy in clinical net adverse clinical events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome who are not the main coronary artery disease.2020 subjects will be enrolled. After PCI,eligible patients will be randomly assigned in a 1:1 ratio to either the optimized antiplatelet therapy group（O-APT）or the standard antiplatelet therapy group（S-APT）. The primary efficacy end points are clinical net adverse clinical events ,or the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, ischemia driven coronary revascularization and stroke at 12 months. The primary safety end point is the incidence of PLATO major bleeding or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
- •Enrollment into the study will require meeting at least one of these clinical syndromes.
- •Unstable angina
- •Non-ST elevation myocardial infarction (NSTEMI)
- •ST elevation MI (STEMI)
- •Non predominant coronary artery disease, it is defined as: exclusion of left main artery disease or left main artery bifurcated disease or ostial left anterior descending disease by coronary angiography imaging, and other high-risk vascular diseases considered by surgeons
- •Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
排除标准
- •Complications during stenting for coronary artery disease
- •Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
- •Any planned surgery within 6 months
- •any reason why any antiplatelet therapy might need to be discontinued within 12 months
- •Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 15ml/min/1.73m^2
- •Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)
- •Platelet count < 100,000 mm^3
- •Contraindication to aspirin
- •Contraindication to ticagrelor
- •Liver cirrhosis
- •Women of child-bearing potential
- •Life expectancy < 1 year
- •Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
研究组 & 干预措施
S-APT group
ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months
干预措施: Ticagrelor plus aspirin (Drug)
O-APT group
Ticagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months
干预措施: Percutaneous coronary intervention (Procedure)
O-APT group
Ticagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months
干预措施: Ticagrelor plus aspirin (Drug)
S-APT group
ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months
干预措施: Percutaneous coronary intervention (Procedure)
结局指标
主要结局
Major cardiovascular and cerebrovascular adverse events
时间窗: Up to 12 months after PCI
Participants with death from cardiovascular causes, non-fatal myocardial infarction, stent thrombosis,Ischemia driven coronary revascularization and ischemic stroke.Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Major bleeding events
时间窗: Up to 12 months after PCI
Plato massive hemorrhage events, including fatal hemorrhage, intracranial hemorrhage, pericardial hemorrhage with pericardial tamponade, hypovolemic shock or severe hypotension caused by hemorrhage, requiring pressor or surgery, hemoglobin level dropping 5.0 g or more per deciliter, or at least requiring blood transfusion. Events were adjudicated by an endpoint committee. BARC type 2, 3 or 5 bleeding. Events were adjudicated by an endpoint committee.
The net adverse clinical events
时间窗: Up to 12 months after PCI
included major adverse cardiovascular and cerebrovascular events or major bleeding events.
次要结局
- Participants with myocardial infarction (MI) event.(Up to 36 months after PCI)
- Participants with death from cardiovascular causes.(Up to 36 months after PCI)
- Participants with death from any cause.(Up to 36 months after PCI)
- PLATO-defined any bleeding event.(Up to 36 months after PCI)
研究者
Lianglong Chen
Professor
Fujian Medical University