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

Phase 2

Completed

• Conditions: Health Condition 1: null- Acute Ischemic Stroke

• Registration Number: CTRI/2009/091/000251
• Lead Sponsor: Gennova Biopharmaceuticals Limited Pune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurological 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 scaleTimepoint: 0 and 24 hours

Secondary Outcome Measures

Name	Time	Method
eurological improvement measured by NIH Stroke Scale at 7 days, 1 month and 3 monthsTimepoint: 0, 7, 30 and 90 days