A clinical trial to evaluate efficacy and safety of R-TPR-004 in patients with acute ischemic stroke

Phase 2

• Conditions: Health Condition 1: null- Acute Ischemic Stroke

• Registration Number: CTRI/2013/04/003590
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 40

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

1. Patient with h/o Recent Stroke <3 months and/or wake-up stroke.

2. Patient with h/o Recent MI <3 weeks.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified