Effect of new drugs sodium ozagrel and edaravone in treatment of stroke

Randomized double blind placebo controlled trial of Sodium ozagrel and Edaravone in acute ischemic stroke - EDOZ

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002644

Enrollment

168

Registered

2012-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute ischaemic Stroke

Interventions

Intervention1: Sodium Ozagrel or Edaravone: Patients eligible to get Sodium Ozagrel or Edaravone will receive 80 mg of Ozagrel or 30 mg Edaravone diluted in 500 ml of saline given over a period of 2 h

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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 10. Congestive cardiac failure or other conditions where saline infusion of 1000 ml/day will be risky

Design outcomes

Primary

Measure	Time frame
Primary outcome measure â??3 month functional outcome assessed using Modified Rankin Scale (MRS) 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: at discharge/death and at 3 months	—

Measure

Time frame

Primary outcome measure â??3 month functional outcome assessed using Modified Rankin Scale (MRS) 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: at discharge/death and at 3 months

—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Sunil Narayan

JIPMER

sunil.narayan@jipmer.edu.in09443617120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026