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

Phase 4CompletedNCT00200356

Shionogi401 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

401

Conditions

Cerebral Infarction

Interventions

EdaravoneDRUG

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

Sodium OzagrelDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the Rate of Patients With a Modified Rankin Scale Score of 0-1

The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.

Time frame: 3 months

Secondary Outcomes

Barthel Index Score

The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state. The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.

Time frame: 3 months

Baseline NIH Stroke Scale Score

The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).

Time frame: Before treatment initiation

NIH Stroke Scale Score at 14 Days

The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.

Time frame: 14 days

NIH Stroke Scale Score at 1 Month

Data from ClinicalTrials.gov

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