NCT00200356

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 of 0-1 at 3 months.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2004

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

January 15, 2013

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

First QC Date

September 12, 2005

Results QC Date

September 13, 2012

Last Update Submit

December 15, 2025

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (9)

  • Barthel Index Score

    3 months

  • Baseline NIH Stroke Scale Score

    Before treatment initiation

  • NIH Stroke Scale Score at 14 Days

    14 days

  • NIH Stroke Scale Score at 1 Month

    1 month

  • NIH Stroke Scale Score at 3 Months

    3 months

  • +4 more secondary outcomes

Study Arms (2)

Edaravone

EXPERIMENTAL
Drug: Edaravone

Ozagrel

ACTIVE COMPARATOR
Drug: Sodium Ozagrel

Interventions

EdaravoneDRUG

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

Also known as: Radicut
Edaravone
Sodium OzagrelDRUG

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

Ozagrel

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shinohara Y, Saito I, Kobayashi S, Uchiyama S. Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial). Cerebrovasc Dis. 2009;27(5):485-92. doi: 10.1159/000210190. Epub 2009 Mar 26.

    PMID: 19321945RESULT

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Edaravoneozagrel

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Yukito Shinohara, MD

    Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2004

Study Completion

October 1, 2006

Last Updated

January 7, 2026

Results First Posted

January 15, 2013

Record last verified: 2025-12