A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Efficacy and Safety of Low Dose Ticagrelor Compared With Standard Dose Ticagrelor in Patients With Unstable Angina Pectoris After Drug Eluting Stent Implantation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2,036
- 试验地点
- 1
- 主要终点
- Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event
研究概览
简要总结
The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.
详细描述
This is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. All patients will receive treatment with aspirin and a P2Y12 inhibitor for 3 months after the index procedure. At 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. The primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. The primary safety end point is the incidence of PLATO major bleeding at 24 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
- 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
- •18 years≤age≤80 years
- •Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
排除标准
- •Allergy or intolerance to ticagrelor or aspirin
- •Need for oral anticoagulation therapy
- •Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
- •Active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
- •High risk of bradyarrhythmias
- •Severe liver dysfunction and abnormal renal function
- •Patient is a woman who is pregnant or nursing
- •Unable or unwilling to give written informed consent
研究组 & 干预措施
Lower dose ticagrelor
Subjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily.
干预措施: Ticagrelor 45 mg (Drug)
Lower dose ticagrelor
Subjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily.
干预措施: Aspirin (Drug)
Standard dose ticagrelor
Subjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily.
干预措施: Ticagrelor 90 mg (Drug)
Standard dose ticagrelor
Subjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily.
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event
时间窗: Randomization up to 24 months
Participants with death from vascular causes, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke. Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. Participants with PLATO major bleeding event including fatal bleeding, intracranial bleeding, intrapericardial bleeding with cardiac tamponade, hypovolemic shock or severe hypotension due to bleeding and requiring pressures or surgery, a decline in the hemoglobin level of 5.0 g per deciliter or more, or the need for transfusion of at least. Events were adjudicated by an endpoint committee.
次要结局
- Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke(Randomization up to 24 months)
- All cause death(Randomization up to 24 months)
- PLATO-defined any bleeding event(Randomization up to 24 months)
研究者
Xiaofan Wu
Chief Physician
Beijing Anzhen Hospital