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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 4

Conditions

Cerebral Infarction

Treatments

Drug: Sodium Ozagrel
Drug: Edaravone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00200356
MCI186-13

Details and patient eligibility

About

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.

Enrollment

401 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

401 participants in 2 patient groups

Edaravone
Experimental group
Treatment:
Drug: Edaravone
Ozagrel
Active Comparator group
Treatment:
Drug: Sodium Ozagrel

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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