A phase III clinical trial study to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in Acute Ischemic Stroke patients

Phase 3

Completed

• Registration Number: CTRI/2015/02/005556
• Lead Sponsor: Gennova Biopharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-10-28
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

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

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 < 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 patientsââ?¬• 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 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 variableTimepoint: 24 hours

Secondary Outcome Measures

Name	Time	Method
eurological improvement measured by NIH Stroke Scale at 7 days, 1 month and at 3 months <br/ ><br> <br/ ><br>Barthel index, modified Rankin scale and Glasgow Outcome scale performed at 7 days, 1 month and 3 monthsTimepoint: 7 days, 1 month and 3 months