CompletedPhase 4

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

401 participantsStarted 2004-08-31

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 months

Trial details

NCT IDNCT00200356

SponsorShionogi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-10-31

Results submitted2012-09-13

View on ClinicalTrials.gov More Cerebral Infarction trials