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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Edaravone

Group Type EXPERIMENTAL

Edaravone

Intervention Type DRUG

Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.

Ozagrel

Group Type ACTIVE_COMPARATOR

Sodium Ozagrel

Intervention Type DRUG

Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

Interventions

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Edaravone

Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.

Intervention Type DRUG

Sodium Ozagrel

Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

Intervention Type DRUG

Other Intervention Names

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Radicut

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No