Health Condition 1: null- Acute Ischemic Stroke
Conditions
Interventions
Intervention1: Tissue plasminogen activator named as R-TPR-004: Dose: 7 ml (7 units)
Duration: Upto 24 hrs.
Frequency: First dose 7 ml (7U)at 0 min
Second dose 7 ml (7U)at 30 min
Mode of administratio
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with Ischemic Stroke of 4.5 hours of symptom onset. 2. Patients with normal or slight early CT signs of ischemic stroke. 3. Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures. 4. Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained on a separate ICF to confirm his/her willingness to continue in the study.
Exclusion criteria
Exclusion criteria: 1. Patient with h/o Recent Stroke 2. Patient with h/o Recent MI 3. High clinical suspicion of septic embolus. 4. Evidence of acute or chronic ICH by head CT. 5. Persistent hypertension with systolic BP >185 mmHg or diastolic BP >110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. 6. Presence or h/o intracranial neoplasm or arteriovenous malformation, intracranial aneurysm, unless surgically treated 3 months. 7. Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. (Major surgical procedures include but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplant). 8. Medical history or evidence of HIV, HBV and HCV infection. 9. Subject participation in another clinical trial 30 days prior to administration of IP. 10. Pregnant and lactating females. 11. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of R-TPR-004 in patients with Acute Ischemic StrokeTimepoint: Neurological improvement in patients as assessed by decrease (improvement) in NIHSS scores from baseline to 24 hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of disability by modified Rankin Scale (mRs) scores Assessment of safetyTimepoint: Decrease in Modified Rankin Scale (mRs) score from baseline to 1 and 3 month. Evaluation of safety will be based on adverse events, physical exams, vital signs, and safety laboratory tests during the study | — |
Countries
India
Contacts
Public ContactDr Parvez Kosgi
Reliance Life Sciences Pvt Ltd
Outcome results
None listed