A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 50
- 主要终点
- Excellent outcome
研究概览
简要总结
The goal of this clinical trial is to learn if a combination of antiplatelet drugs works better than intravenous tissue plasminogen activator to treat small ischemic stroke (lacunar stroke). The main questions it aims to answer are:
Is a combination of antiplatelet drugs non-inferior to the current standard tissue plasminogen activator treatment? Does a combination of antiplatelet drugs reduce the bleeding complications than tissue plasminogen activator?
Researchers will compare a combination of antiplatelet drugs to tissue plasminogen activator to see if a combination of antiplatelet drugs works to treat small ischemic stroke (lacunar stroke).
Participants will:
Take a combination of antiplatelet drugs or be given intravenous tissue plasminogen activator Check the neurological status 3 months after stroke, in-person, by phone, or by mail.
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
- •Age ≥ 18 years.
- •Acute ischemic stroke within 4.5 hours from onset. If onset time is unknown because of impaired consciousness or aphasia, use the "last known well" time.
- •A single perforating-artery infarct on brain MRI:
- •located in the corona radiata, putamen, internal capsule, thalamus, or pons; solitary, mainly round or oval, with a maximum diameter ≤ 20 mm; lesions only in the centrum semiovale are not allowed, but extension from the above sites into the centrum semiovale is allowed.
- •No disability in daily life before the stroke (modified Rankin Scale ≤ 1).
- •National Institutes of Health Stroke Scale (NIHSS) score ≤
- •Written informed consent obtained.
排除标准
- •Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions.
- •Any contraindication to intravenous rt-PA, without blood pressures.
- •≥ 50 % stenosis or occlusion of the artery responsible for the stroke * (see note below).
- •Diseases that require anticoagulation (e.g., atrial fibrillation, deep-vein thrombosis) *
- •Inability to take medicine orally.
- •Any other reason judged by the principal investigator or co-investigators to make participation inappropriate.
- •Note: This study targets hyper-acute stroke within 4.5 hours. To avoid treatment delay, items marked with * must be judged using the similar examinations that each site normally performs before rt-PA administration.
研究组 & 干预措施
DAPT
干预措施: DAPT (Drug)
rt-PA
干预措施: rt-PA (Drug)
结局指标
主要结局
Excellent outcome
时间窗: 3 months after stroke
Modified Rankin scale score of 0-1
次要结局
- Infarct growth between Day 7 and admission(At Day 7)
- Early neurological deterioration(At Day 7)
- NIHSS score on Day 7(At Day 7)
- Good outcome(At 3 months)
- mRS distribution at 3 months(At 3 months)
- Ischemic stroke recurrence(At 3 months)
- Cost effectiveness of DAPT(Various (such as at 7 days or 3 months))
研究者
Yuki Sakamoto
Associate Professor
Nippon Medical School