Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 17
- 主要终点
- Neurological improvement at 24 hours as indicated by neurological improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale
研究概览
简要总结
The objective of the present study is to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in the treatment of acute ischemic stroke at the doses of 0.1 mg/kg and 0.2 mg/kg. This will be an open label, randomized, multi-centric clinical trial conducted in 50 patients at neurology centers across India. Patients with acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS) within 3 hours of onset, aged 18-75 years will be enrolled. Patients recovering from stroke, with any bleeding disorder, on anticoagulant therapy, with uncontrolled hypertension, myocardial infarction, seizures, pre-existing neurological or psychiatric disease and pregnant patients will be excluded from the study. Patients will be randomized to receive either the dose of 0.1 mg/kg or 0.2 mg/kg. Tenecteplase will be administered as an IV bolus over 5-10 seconds within 3 hours of onset of stroke. The primary efficacy variable will be neurological improvement at 24 hours as indicated by neurological improvement of ≥ 8 point or a score of 0 on the NIH Stroke scale. This will be expressed as percentage of responders and will be compared. The secondary efficacy variables will be neurological improvement measured by NIH Stroke Scale, Barthel index, modified Rankin scale and Glasgow Outcome scale measured at 7 days, 1 month and 3 months. The safety variables will be percentage of patients suffering from symptomatic intracranial hemorrhage within 36 hours of treatment and percentage of patients with asymptomatic intracranial bleeding detected on CT scan at 48 hours of treatment. The safety variables will be analyzed using percentages and proportions. For all statistical tests a p-value of ≤ 0.05 will be considered as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Day(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS)
- •Treatment within 3 hours of stroke onset
- •Age 18 to 75 years 4.
排除标准
- •Minor stroke symptoms or major symptoms rapidly improving
- •Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan
- •Pregnancy
- •Patient taking oral anticoagulants.
- •Patients who have received heparin within 48 hours
- •Major surgery or serious trauma within 14 days; serious head trauma within 3 months
- •Gastrointestinal or urinary tract hemorrhage within 21 days
- •Arterial puncture at a noncompressible site or lumbar puncture within 7 days
- •Uncontrolled baseline hypertension ( >185/110 mm Hg)
- •Clinical stroke within 3 months or history of intracranial hemorrhage
- •Myocardial infraction in past 30 days
- •Other serious medical illness likely to interfere with treatment or treatment might adversely affect that illness
- •Seizure at stroke onset
- •Any other investigational drug within 14 days
- •Unlikely to complete the protocol follow-up
- •Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
结局指标
主要结局
Neurological improvement at 24 hours as indicated by neurological improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale
时间窗: 0 and 24 hours
次要结局
- Neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and 3 months(0, 7, 30 and 90 days)