Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,084
- 试验地点
- 1
- 主要终点
- Proportion of patients of modified Rankin Scale (mRS)≤1
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
详细描述
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size.
Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.
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
- •Age≥18 years old;
- •Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;
- •Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;
- •Tirofiban or placebo treatment can be initiated within 6h after IVT;
- •mRS score before onset≤ 1;
- •Intracranial hemorrhage is ruled out by CT head after IVT;
排除标准
- •Received or plan to undergo bridge therapy;
- •Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
- •Atrial fibrillation or suspected cardiac embolism;
- •Accompanied by epileptic seizures;
- •Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
- •Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
- •Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
- •Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L；
- •Life expectancy less than 3 months;
- •Pregnant or lactating women;
- •Known allergy to tirofiban;
- •Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
- •Patients who are unwilling to be followed up or likely to have poor treatment compliance;
- •Other situations that the researcher deems unsuitable for inclusion in the study.
研究组 & 干预措施
Tirofiban group
Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT
干预措施: Tirofiban (Drug)
Tirofiban simulant group
Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT
干预措施: Tirofiban simulant (Drug)
结局指标
主要结局
Proportion of patients of modified Rankin Scale (mRS)≤1
时间窗: 90±7 days
mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome
次要结局
- Proportion of patients of mRS≤2(90±7 days)
- Distribution of mRS(90±7 days)
- National Institute of Health stroke scale (NIHSS)(24 hours after IVT, 7 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University