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

Cerebral Infarction Clinical Trial

Official title:

Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200356
• Other study ID #: MCI186-13
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 9, 2012
• Start date: August 2004
• Est. completion date: October 2006

Study information

• Verified date: December 2012
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction

Intervention

Drug:
• Edaravone
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
• Sodium Ozagrel
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	3 months	No
Secondary	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).	Before treatment initiation	No
Secondary	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.	14 days	No
Secondary	NIH Stroke Scale Score at 1 Month	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 1 month after treatment initiation.	1 month	No
Secondary	NIH Stroke Scale Score at 3 Months	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 3 months after treatment initiation.	3 months	No
Secondary	Japan Stroke Scale (Motor Function) Score at 14 Days	The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.	14 days	No
Secondary	Japan Stroke Scale (Motor Function) Score at 1 Month	The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.	1 month	No
Secondary	Japan Stroke Scale (Motor Function) Score at 3 Months	The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.	3 months	No
Secondary	Modified Rankin Scale Score	The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale 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.	6 months	No