Effect of new drugs sodium ozagrel and edaravone in treatment of stroke
- Conditions
- Health Condition 1: null- Acute ischaemic Stroke
- Registration Number
- CTRI/2012/05/002644
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 168
1.Patients with atherothrombotic stroke presenting after 4.5 hrs and within 24 hrs of onset with objective neurological deficits
2.Above 18 years of age and gives informed consent (patient/relative)
1.Cardio embolic stroke
2.Intracerebral hemorrhage (including subarachnoid hemorrhage, subdural hemorrhage, extradural hemorrhage)
3.Patients who have received thrombolytic therapy tPA
4.Patients who are receiving heparin for any reason
5.Renal impairment (creatinine >2 mg/dl)
6.Hepatic dysfunction (clinical or abnormal LFT)
7.Bleeding diathesis
8.Recent major surgery within one month or minor surgery within two weeks of stroke
9.NIHSS <4 or more than 22.
10.Congestive cardiac failure or other conditions where saline infusion of 1000 ml/day will be risky
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure â??3 month functional outcome assessed using Modified Rankin Scale (MRS) <br/ ><br> <br/ ><br>Secondary outcome measures- NIH score or SSS and Barthel index at day 14 and 1 month, Intracranial haemorrhage, Renal failure, hepatic dysfunction or any unexplained organ function abnormality, seventh day and thirtieth day. All adverse events and SAEs will be reported as per GCP guidelines. <br/ ><br>Timepoint: at discharge/death and at 3 months
- Secondary Outcome Measures
Name Time Method Secondary outcome measures- NIH score or SSS and Barthel index at day 14 and 1 month, Intracranial haemorrhage, Renal failure, hepatic dysfunction or any unexplained organ function abnormality, seventh day and thirtieth day. All adverse events and SAEs will be reported as per GCP guidelines.Timepoint: day 0, 14 and 1 month