Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 580
- 试验地点
- 18
- 主要终点
- Proportion of excellent functional outcomes (mRS 0-1)
研究概览
简要总结
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
详细描述
Although dual antiplatelet therapy (DAPT) reduces stroke recurrence and disability risks, its efficacy is limited in patients with mild ischemic stroke (NIHSS ≤5), among whom early neurological deterioration (END) and poor functional outcomes are frequently observed. Notably, intravenous thrombolysis is not more effective than DAPT for mild stroke management. Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has shown potential efficacy in mild-to-moderate ischemic stroke, but robust evidence specific to mild stroke remains lacking. This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
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
- •Age: 18-80 years old.
- •Acute mild non-cardioembolic stroke.
- •NIHSS score ≤
- •Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.
- •The investigational drug can be administered within 48 hours of symptom onset.
- •Signed informed consent by the patient or legally authorized representative.
排除标准
- •Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
- •Intracranial hemorrhage confirmed by imaging.
- •Pre-stroke modified Rankin Scale (mRS) score ≥
- •Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction <30%.
- •History of primary intracerebral hemorrhage.
- •History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
- •Untreated or inadequately treated intracranial aneurysm or vascular malformation.
- •Major systemic bleeding within 30 days.
- •Active bleeding, including laboratory evidence of coagulopathy (platelet count <100 × 10⁹/L, activated partial thromboplastin time >50 seconds, or international normalized ratio >1.7), or treatment with direct oral anticoagulants within the preceding 48 hours.
- •Major surgery within 14 days.
- •Persistently elevated blood pressure (systolic >180 mmHg or diastolic >110 mmHg) despite treatment.
- •Baseline platelet count <100 × 10⁹/L.
- •Severe renal dysfunction (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L [2.5 mg/dL]).
- •Known allergy or contraindication to tirofiban or aspirin.
- •Current pregnancy or lactation.
- •Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).
- •Any terminal illness with life expectancy <6 months.
研究组 & 干预措施
Tirofiban+Oral Dual Antiplatelet Therapy
Patients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter
干预措施: Tirofiban+Oral Dual Antiplatelet Therapy (Drug)
oral dual antiplatelet therapy
Patients will receive oral dual antiplatelet therapy alone
干预措施: Oral Dual Antiplatelet Therapy (Drug)
结局指标
主要结局
Proportion of excellent functional outcomes (mRS 0-1)
时间窗: 90 days
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death)
次要结局
- Incidence of early neurological deterioration(72 hours)
- Incidence of early neurological improvement(72 hours)
- Change in National Institutes of Health Stroke Scale score from baseline(7 days)
- Proportion of good functional outcomes (mRS 0-2)(90 days)
- Distribution of mRS scores(90 days)
- Incidence of schemic stroke(90 days)
- Incidence of major adverse cardiovascular events(90 days)
- Rate of symptomatic intracerebral hemorrhage(7 days)
- Rate of all-cause mortality(90 days)
- Rate of major bleeding events(90 days)