None listed
Conditions
Interventions
Intervention1: Tenecteplase (TNK-TPA): Each vial contains:
Recombinant Tissue Plasminogen Activator (TNK-t-PA)20 mg
As lyophilized powder to be reconstituted with 10 ml of sterile water for injection
Sponsors
Gennova Biopharmaceuticals Ltd
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 variableTimepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 monthsTimepoint: 7 days, 1 month and 3 months | — |
Countries
India
Contacts
Public ContactDr Rajeshkumar Singh
Gennova Biopharmaceuticals Limited
Outcome results
None listed