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

Phase 2/3

Completed

• Conditions: Acute Ischemic Stroke

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

Brief Summary

The objective of the present study is to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in the treatment of acute ischemic stroke at the doses of 0.1 mg/kg and 0.2 mg/kg. This will be an open label, randomized, multi-centric clinical trial conducted in 50 patients at neurology centers across India. Patients with acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS) within 3 hours of onset, aged 18-75 years will be enrolled. Patients recovering from stroke, with any bleeding disorder, on anticoagulant therapy, with uncontrolled hypertension, myocardial infarction, seizures, pre-existing neurological or psychiatric disease and pregnant patients will be excluded from the study. Patients will be randomized to receive either the dose of 0.1 mg/kg or 0.2 mg/kg. Tenecteplase will be administered as an IV bolus over 5-10 seconds within 3 hours of onset of stroke. The primary efficacy variable will be neurological improvement at 24 hours as indicated by neurological improvement of ≥ 8 point or a score of 0 on the NIH Stroke scale. This will be expressed as percentage of responders and will be compared. The secondary efficacy variables will be neurological improvement measured by NIH Stroke Scale, Barthel index, modified Rankin scale and Glasgow Outcome scale measured 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 and percentage of patients with asymptomatic intracranial bleeding detected on CT scan at 48 hours of treatment. The safety variables will be analyzed using percentages and proportions. For all statistical tests a p-value of ≤ 0.05 will be considered as significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-25
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• Minor stroke symptoms or major symptoms rapidly improving 2.
• Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan 3.
• Pregnancy 5.
• Patient taking oral anticoagulants.
• 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.
• Any other investigational drug within 14 days 18.
• 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 of more than or equal to 8 points or a score of 0 on the NIH Stroke scale	0 and 24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (17)

Baby Memorial Hospital; 🇮🇳 Road,-673, India

Criticare Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Dhanalakshmi Hospital; 🇮🇳 Kannur, KERALA, India

Elite Hospital; 🇮🇳 Thrissur, KERALA, India

Kurza Nursing Home; 🇮🇳 Mumbai, MAHARASHTRA, India

Laddhed Hospital; 🇮🇳 Wankhede, layout,, India

M.S. Ramaiah Memorial Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Mallikatta Neurocentre; 🇮🇳 Bangalore, KARNATAKA, India

Mother Hospital Pvt Ltd; 🇮🇳 Thrissur, KERALA, India

Popular Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

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Baby Memorial Hospital

🇮🇳Road,-673, India

Dr. K. Abdul Salam

Principal investigator