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Stroke drug showdown: which helps recovery more?

NCT ID NCT00200356

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study compared two medications, edaravone and sodium ozagrel, for treating acute ischemic stroke. Researchers wanted to see which drug helped more people recover with little or no disability three months after treatment. The study included 401 adults who started treatment within 24 hours of their stroke.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

401 people

The number who actually took part.

Started

Aug 2004

Finished

Oct 2006

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cerebral infarction ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral infarction

More trials for these conditions

Other studies related to the condition(s) this trial covers.