Intravenous Tirofiban Versus Placebo After Delayed Thrombolysis (4.5-24h) in Acute Ischemic Stroke (PEARL-TIRO): A Multicenter, Double-Blind, Double-Dummy, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 852
- 试验地点
- 1
- 主要终点
- The modified Rankin Scale score (mRS) 0-1
研究概览
简要总结
A multicenter, double-blind, double-dummy, randomized trial evaluating the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT).
详细描述
This study is a multicenter, double-blind, double-dummy, randomized clinical trial designed to evaluate the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT). The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1.
Study intervention: (1) Participants in the intervention group will receive intravenous tirofiban as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach.
All participants will receive standard medical treatment.
A total of 852 participants are anticipated to be recruited for this study, with 426 participants in each group (1:1 ratio).
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Aged 18 years or older;
- •Clinical diagnosed acute ischemic stroke (AIS) with last known well time of 4.5-24 hours;
- •Any of the following presentation of AIS:
- •Treated with IVT followed by no significant change in neurological function; 2) Treated with IVT followed by early neurological deterioration;
- •NIHSS score ≥4 before randomization;
- •Able to receive the designated study drug within 60 minutes after IVT;
- •Written informed consent is obtained from patients and/or their legal representatives.
排除标准
- •Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history;
- •CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1 or M2 segment, anterior cerebral artery A1 segment, and vertebrobasilar artery;
- •Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%;
- •Pre-stroke modified Rankin scale (mRS)≥2;
- •Renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L [2.5 mg/dl]);
- •Pregnant or lactating women;
- •NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS < 6;
- •Allergy to tirofiban, other glycoprotein IIb/IIIa inhibitors, aspirin or clopidogrel;
- •History of bleeding disorder, severe heart, liver or kidney disease, or sepsis;
- •Active bleeding diathesis, including clinical laboratory evidence of coagulation abnormalities (platelet count < 100×10⁹/L, activated partial thromboplastin time >50 seconds or international normalized ratio > 1.7), or treatment with a direct oral anticoagulant within the prior 48h;
- •CT or MR evidence of mass effect or intracranial tumor (except small meningioma);
- •CT or MR angiography evidence of intracranial arteriovenous malformations or aneurysm;
- •Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast;
- •Any terminal illness with life expectancy less than 6 months;
- •Participating in other clinical trials;
- •Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.
研究组 & 干预措施
Tirofiban group
干预措施: Tirofiban (Drug)
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
The modified Rankin Scale score (mRS) 0-1
时间窗: 90 (±14) days
The proportion of mRS score 0-1 at 90 (±14) days.
次要结局
- Distribution of modified Rankin Scale score at 90 days(90 (±14) days)
- The modified Rankin Scale score 0-2(90 (±14) days)
- Early neurological improvement(48 (±12) hours)
- Quality of life (EQ-5D-5L)(90 (±14) days)