Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke

Gennova Biopharmaceuticals Limited Pune0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. 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 consent before study procedure

•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 < 100 000 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.

发起方

Gennova Biopharmaceuticals Limited Pune