Clinical trial NCT00200356: Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Official title: Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 401
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the Rate of Patients With a Modified Rankin Scale Score of 0-1
timeFrame: 3 months
Secondary outcomes:
measure: Barthel Index Score
timeFrame: 3 months
measure: Baseline NIH Stroke Scale Score
timeFrame: Before treatment initiation
measure: NIH Stroke Scale Score at 14 Days
timeFrame: 14 days
measure: NIH Stroke Scale Score at 1 Month
timeFrame: 1 month
measure: NIH Stroke Scale Score at 3 Months
timeFrame: 3 months
measure: Japan Stroke Scale (Motor Function) Score at 14 Days
timeFrame: 14 days
measure: Japan Stroke Scale (Motor Function) Score at 1 Month
timeFrame: 1 month
measure: Japan Stroke Scale (Motor Function) Score at 3 Months
timeFrame: 3 months
measure: Modified Rankin Scale Score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
name: Yukito Shinohara, MD
role: STUDY_CHAIR
References:
citation: 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.