Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,220
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebral events (MACCEs)
研究概览
简要总结
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.
详细描述
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
- •Able and willing to provide informed consent and participate in 12 months follow-up period
- •Able to receive DAPT treatment
- •Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria.
- •Clinical inclusion criteria:
- •Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative <55 years old or in first-degree female relative <65 years old)
- •Repeated myocardial infarction
- •Positive serum cardiac troponin I/T
- •Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
- •Type 2 diabetes mellitus under medication
- •Chronic kidney disease (eGFR<60 mL/min/1.73 m2 or CrCl<60ml/min)
- •Angiographic Inclusion Criteria:
- •LM lesion requiring stents
- •Proximal LAD lesion(s) requiring stents
- •Bypass grafts lesion(s) requiring stents
- •Overall stent length ≥60 mm
- •History of in-stent thrombosis
- •Bifurcation lesions requiring at least 2 stents
- •Over two vessels lesions requiring stents
- •Calcified target lesion(s) requiring atherectomy
- •The intraoperative occurrence of no-reflow or slow-flow
- •Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)
排除标准
- •Need for chronic oral anticoagulation
- •With cardiomyopathy（HCM/DCM/RCM）
- •With severe ventricular arrhythmia requiring ICD implantation
- •With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
- •With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）
- •With hematological disorders（thrombocytopenia, severe anemia, leukaemia）
- •With severe liver disease or kidney failure
- •With malignant tumor
- •With cognitive impairment
- •Unable or unwilling to provide informed consent or undergo follow-up
研究组 & 干预措施
LD group
Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months
干预措施: Aspirin (Drug)
LD group
Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months
干预措施: Ticagrelor (Drug)
Control group
Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months
干预措施: Aspirin (Drug)
Control group
Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Major adverse cardiac and cerebral events (MACCEs)
时间窗: 12 months after randomization
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
次要结局
- Bleeding-related withdrawal(12 months after randomization)
- Bleeding episode (Key secondary endpoint)(12 months after randomization)
- Platelet function(12 months after randomization)
- Medication adherence(12 months after randomization)
研究者
Qian Haiyan
MD, PhD
Fu Wai Hospital, Beijing, China