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

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-20
• Study Completion: 2016-10-28
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

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 patients’ inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Apollo Speciality Hospitals; 🇮🇳 Madurai, TAMIL NADU, India

Dr. Ramesh Cardiac & Multispeciality Hospital Ltd.; 🇮🇳 Guntur, ANDHRA PRADESH, India

Dr. Ramesh Cardiac and Multispeciality Hospital Pvt Ltd.; 🇮🇳 Guntur, ANDHRA PRADESH, India

Fortis Escorts Hospital; 🇮🇳 Faridabad, HARYANA, India

Fortis Escorts Hospitals; 🇮🇳 Amritsar, PUNJAB, India

Fortis Hospital; 🇮🇳 Nagar, UTTAR PRADESH, India

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, HARYANA, India

Jawaharlal Institute of Postgraduate Medical Education And Research [JIPMER]; 🇮🇳 Pondicherry, PONDICHERRY, India

K G Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Lalitha Super Specialities Hospital Pvt. Ltd; 🇮🇳 Guntur, ANDHRA PRADESH, India

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Apollo Speciality Hospitals

🇮🇳Madurai, TAMIL NADU, India

Dr Meenakshi Sundaram Salvadeeswaran

Principal investigator

9842980211

drsundarsms@gmail.com