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

Conditions

Health Condition 1: null- Acute Ischemic Stroke

Anil Gulati, Sikandar Adwani, Vijaya Pamidimukkala, Nilesh Agrawal, TCR Ramakrishnan et al. (19 authors)

Drugs2024-11-153 citations

Efficacy and Safety of Intravenous Tenecteplase Bolus in Acute Ischemic Stroke: Results of Two Open-Label, Multicenter Trials.

Ramakrishnan TCR, Kumaravelu S, Narayan SK, Buddha SS, Murali C, Majeed PHA, Meenakshi-Sundaram S, Wadia RS, Sharma V, Basu I, Vijaya P, Salam KA, Barmare S, Vaid Z, Nirmal Raj KK, Wattamwar PR, Asokan K, Dhonge V, Nellikunja S, Namjoshi D, Srinivasa R, Laddhad DS, Deshpande SD, Raghunath B, Kalita J, Kumar M, Misra UK, Pradeep M, Tenecteplase in Stroke Investigators.

2018-10-0117 citations

10.1007/s40256-018-0284-1

Interventions

Intervention1: Tenecteplase (TNK-TPA): Injection Tenecteplase (TNK-TPA)0.1 or 0.2 mg/kg IV bolus Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

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 patients inclusion in the study.

Design outcomes

Primary

Measure	Time frame
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 scaleTimepoint: 0 and 24 hours	—

Secondary

Measure	Time frame
Neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and 3 monthsTimepoint: 0, 7, 30 and 90 days	—

Countries

India

Contacts

Public ContactDr Sandeep Sonawane

Sandeep.Sonawane@emcure.co.in020-39821000

Outcome results

None listed