Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 19
- 主要终点
- Neurological improvement at 24 hours as indicated by neurological improvement defined prospectively as an improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale will be taken as primary efficacy variable
研究概览
简要总结
The objective of the present study is to assess the efficacy and safety of TNK-TPA in acute ischemic stroke. A total of 75 patients will be enrolled in an open label & multi-centric clinical trial conducted across India. All the patients will receive thrombolytic therapy with TNK-TPA and appropriate background therapy. TNK-TPA will be administered in the dose of 0.2 mg/kg as IV bolus over 5-10 seconds. Neurological improvement at 24 hours as indicated by neurological improvement defined prospectively as an improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale will be taken as primary efficacy variable. Secondary efficacy variables will be neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and at 3 months & Barthel index, modified Rankin scale and Glasgow Outcome scale performed 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 & percentage of patients with asymptomatic intracranial bleeding detected on CT scan at 48 hours of treatment.
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 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS) 2.Treatment within 3 hours of stroke onset 3.Age 18 to 75 years 4.Patient or legally acceptable representative willing to give informed written consent before study procedure.
排除标准
- •1.Minor stroke symptoms, or major symptoms rapidly improving 2.Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan 3.Clinical presentation suggesting subarachnoid haemorrhage 4.Pregnancy 5.Known bleeding diathesis and/or platelet count < 100000 mm3 6.Patient taking oral anticoagulants 7.Patients who have received heparin within 48 hours 8.Major surgery or serious trauma within 14 days; serious head trauma within 3 months 9.Gastrointestinal or urinary tract hemorrhage within 21 days 10.Arterial puncture at a noncompressible site or lumbar puncture within 7 days 11.Uncontrolled baseline hypertension ( >185/110 mm Hg) 12.Clinical stroke within 3 months or history of intracranial hemorrhage 13.Myocardial infraction in past 30 days 14.Other serious medical illness likely to interfere with treatment or treatment might adversely affect that illness 15.Seizure at stroke onset 16.Confounding pre-existent neurological or psychiatric disease 17.Any other investigational drug within 14 days 18.Large areas (greater than one lobe) of obvious low density on baseline head CT scan 19.Unlikely to complete the protocol follow-up 20.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 defined prospectively as an improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale will be taken as primary efficacy variable
时间窗: 24 hours
次要结局
- Neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and at 3 months(Barthel index, modified Rankin scale and Glasgow Outcome scale performed at 7 days, 1 month and 3 months)