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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