Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Antipyrine; Edaravone; Ozagrel; Phenylmethylpyrazolone

Criteria

Inclusion Criteria:

1. Patients can be receive drug treatment within 24 hours after stroke onset

2. Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale

3. Patients with motor dysfunction of upper and/or lower extremities

4. Patients aged 20 years or older when giving informed consent

Exclusion Criteria:

1. Serum creatinine of >1.5 mg/dL

2. Embolic infarction

3. Intracranial haemorrhage

4. Large infarction with severe consciousness

5. Transient ischemic attack (TIA)

6. A modified Rankin Scale score of ≥2 before stroke onset

7. Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset

8. Patients were receive surgical treatment or intravascular treatment

9. With severe complications (cirrhosis, heart failure, etc.)

10. Treating malignant tumor

11. Pregnant or possibly pregnant women, nursing mothers

12. History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity

13. Less than 3 months since any other clinical trial or postmarketing study