Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Composite endpoint of ischemic cardiovascular events and major bleeding
研究概览
简要总结
The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis.
详细描述
The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis. Target sample size is 400. The primary outcome is a composite endpoint of ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization) and major bleeding defined by the International Society on Thrombosis and Haemostasis(ISTH) criteria within 2 years after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days from the onset of symptoms
- •Age 20 or older
- •Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant
- •Patients who have one of the following atherothrombotic diseases
- •A past history of ischemic heart disease (myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
- •A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting)
- •Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA))
- •Intracranial artery stenosis (=>50% stenosis of the diameter of a major intracranial artery: intracranial internal carotid artery, anterior cerebral artery (ACA)-A1 and A2, middle cerebral artery (MCA)-M1 and M2, posterior cerebral artery (PCA)-P1 and P2, vertebral artery, and basilar artery; a history of intracranial stent placement or intracranial bypass surgery)
- •A past history of atherothrombotic brain infarction, lacunar infarction, or branch atheromatous disease
- •Patients without severe disability (modified Rankin Scale score =<4)
- •Patients who can take oral medications
- •Patients who can receive follow-up survey
- •Provision of written informed consent either directly or by a suitable surrogate
排除标准
- •History of myocardial infarction or acute coronary syndrome within the past 12 months
- •Patients who underwent PCI with drug-eluting stents within the past 12 months or PCI with bare-metal stents within the past 3 months
- •Patients who underwent carotid artery stent placement, intracranial stent placement, or lower extremity stent placement within the past 3 months
- •History of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the past 6 months
- •Hemorrhagic diathesis or blood coagulation disorders
- •Platelet counts <100,000 /mm3 at enrollment.
- •Severe anemia (hemoglobin <7 g/dL)
- •Severe renal failure (creatinine clearance =<15 mL/min) or undergoing chronic hemodialysis.
- •Severe liver dysfunction (Grade B or C of the Child-Pugh classification)
- •Patients with severe disability requires constant nursing care, bedridden (modified Rankin Scale score =5)
- •Pregnant or possibly pregnant women
- •Active cancer
- •Expectation of survival less than 2 years
- •Anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during the follow-up period
- •Planned revascularization procedure during the follow-up period
- •Patients who are enrolled in other trials
- •Patients judged as inappropriate for this study by investigators
研究组 & 干预措施
Dual-therapy group
Dual-therapy group: single anticoagulant drug and single antiplatelet drug. The dosage is determined according to each drug's package insert in Japan. In patients treated with warfarin, the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
干预措施: Oral Anticoagulant (Drug)
Dual-therapy group
Dual-therapy group: single anticoagulant drug and single antiplatelet drug. The dosage is determined according to each drug's package insert in Japan. In patients treated with warfarin, the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
干预措施: Antiplatelet Drug (Drug)
Single-therapy group
Single-therapy group: single anticoagulant drug. The dosage is determined according to each drug's package insert in Japan. In patients treated with warfarin, the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
干预措施: Oral Anticoagulant (Drug)
结局指标
主要结局
Composite endpoint of ischemic cardiovascular events and major bleeding
时间窗: 2 years after randomization
One of the following ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, or ischemic events requiring urgent revascularization), or major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
次要结局
- Myocardial infarction and cardiovascular death(2 years after randomization)
- All-cause mortality(2 years after randomization)
- Ischemic cardiovascular events(2 years after randomization)
- All ischemic cardiovascular events including transient ischemia(2 years after randomization)
- Ischemic stroke(2 years after randomization)
- major bleeding(2 years after randomization)
- Intracranial hemorrhage(2 years after randomization)
研究者
Hiroshi Yamagami
Director, Department of Stroke Neurology
National Hospital Organization Osaka National Hospital