Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
详细描述
The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.
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)
盲法说明
randomized, double-blind trial
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
- •Onset of ischemic stroke symptoms within ≤ 4.5 hours*, treated with intravenous rt-PA or TNK according to guidelines;
- •NIHSS score of 4-25 before intravenous thrombolysis;
- •Age ≥ 18 years;
- •Able to receive the designated study drug within 60 minutes after intravenous thrombolysis;
- •Informed consent signed by the patient or their legal representative. *Symptom onset is defined as the last known well time.
排除标准
- •Presence of contraindications to intravenous thrombolysis;
- •Pre-stroke mRS score > 1;
- •Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);
- •Patients with a history of atrial fibrillation or emergency ECG indicating atrial fibrillation;
- •Pregnant or lactating women;
- •NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS < 6;
- •If NIHSS worsens by 2 or more points between start of thrombolysis and start of study drug, repeat brain imaging rules out new intracranial hemorrhage;
- •Severe leukoaraiosis;
- •Currently participating in other clinical trials;
- •Known genetic or acquired bleeding diathesis, or received warfarin and INR > 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;
- •Severe renal failure, defined as serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate [GFR] < 30, or patients requiring hemodialysis or peritoneal dialysis;
- •Liver dysfunction (ALT > 2 times the upper limit of normal or AST > 2 times the upper limit of normal);
- •Known allergy to tirofiban or other IIb/IIIa inhibitors;
- •Life expectancy < 1 year;
- •Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients, etc.).
研究组 & 干预措施
Intravenous thrombolysis plus tirofiban administration
Patients will receive Intravenous thrombolysis and tirofiban administration
干预措施: Intravenous thrombolysis plus tirofiban (Drug)
Intravenous thrombolysis plus placebo administration
Patients will receive Intravenous thrombolysis and placebo (saline) administration
干预措施: Intravenous thrombolysis plus placebo (Drug)
结局指标
主要结局
mortality
时间窗: 90 (± 14 days) after procedure
(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
symptomatic intracerebral hemorrhage (ICH)
时间窗: within 36 hours after procedure
SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 36 hours or any hemorrhage leading to death.
a modified Rankin Score of 0-1
时间窗: 90 (± 14 days) after procedure
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
次要结局
- NIHSS score(24 hours after procedure)
- a modified Rankin Score of 0-3(90 (± 14 days) after procedure)
- Modified Rankin Score(90 (± 14 days) after procedure)
研究者
Wei Hu
professor
The First Affiliated Hospital of University of Science and Technology of China