Status:
COMPLETED
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Cerebral Infarction
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Patients can be receive drug treatment within 24 hours after stroke onset
- 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
- Patients with motor dysfunction of upper and/or lower extremities
- Patients aged 20 years or older when giving informed consent
Exclusion
- Serum creatinine of \>1.5 mg/dL
- Embolic infarction
- Intracranial haemorrhage
- Large infarction with severe consciousness
- Transient ischemic attack (TIA)
- A modified Rankin Scale score of ≥2 before stroke onset
- Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset
- Patients were receive surgical treatment or intravascular treatment
- With severe complications (cirrhosis, heart failure, etc.)
- Treating malignant tumor
- Pregnant or possibly pregnant women, nursing mothers
- History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity
- Less than 3 months since any other clinical trial or postmarketing study
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00200356
Start Date
August 1 2004
End Date
October 1 2006
Last Update
January 7 2026
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