A Prospective, multi-centric, single-arm, clinical study toevaluate efficacy and safety of R-TPR-004 in patients undergoing treatment for acute ischemic stroke

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•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.

发起方