Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 348
- 试验地点
- 38
- 主要终点
- Excellent functional outcome
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.
详细描述
Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.
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;
- •Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);
- •NIHSS ≥ 4 points before randomization;
- •The patient or their family members sign a written informed consent form.
排除标准
- •Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
- •CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery;
- •Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction <40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk;
- •Blood platelet count was lower than 100×10^9/L;
- •Renal insufficiency, glomerular filtration rate < 30 mL/min;
- •Pregnant or lactating women;
- •Allergic to tirofiban, nickel, titanium or their alloys;
- •Prior neurological or psychiatric illness that prevents assessment of neurological function;
- •Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
- •Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
- •Intracranial aneurysm, arteriovenous malformation;
- •Life expectancy of any advanced disease < 6 months;
- •Participating in other clinical trials.
研究组 & 干预措施
Tirofiban
Patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the tirofiban group will be treated with intravenous tirofiban. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Tirofiban will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
干预措施: Tirofiban Hydrochloride (Drug)
Placebo
All patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the placebo group will be treated with intravenous saline. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Placebo will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Excellent functional outcome
时间窗: 90 days post-randomization
modified Rankin scale score of 0 to 1. modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
次要结局
- Ordinal degree of disability(90 days post-randomization)
- Functionally independent(90 days post-randomization)
- Ambulatory or bodily needs capable or better(90 days post-randomization)
- Early neurologic improvement(48 hours post-randomization)
- Health-related quality of life(90 days post-randomization)
- Symptomatic intracranial hemorrhage(48 hours post-randomization)
- Radiologic intracranial hemorrhage rate(48 hours post-randomization)
- Mortality(90 days post-randomization)
- Incidence of non-hemorrhagic serious adverse events(Within 90 days post-randomization)
- Other serious adverse events(Within 90 days post-randomization)
研究者
Jian Zhang, MD
Research assistant
Second Affiliated Hospital of Guangxi Medical University