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

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

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 criteria

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