Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke

NCT ID: NCT02643784

Last Updated: 2015-12-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-07-31

Brief Summary

This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.

Detailed Description

This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.

Conditions

Ischemic

Keywords

acute ischemic stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

Rosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day).

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days.

Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.

Control

Intervention Type: OTHER

Randomized Treatment Period (Day 1 through Day 14):

No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.

Control

Control group(don't take rosuvastatin until 14th day), as directed by the study physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rosuvastatin

Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days.

Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.

Intervention Type: DRUG

Control

Randomized Treatment Period (Day 1 through Day 14):

No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.

Intervention Type: OTHER

Other Intervention Names

RSV

Eligibility Criteria

Inclusion Criteria

1. 45 to 75 years old patients;

2. Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;

3. Time from symptom onset to take the study assigned medication is within 24 hours;

4. Statin naïve or discontinued at least 3 month before stroke onset;

5. First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;

6. Moderate neurological deficit with baseline NIHSS scoring from 4-20;

7. MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset;

8. Consent form signed.

Exclusion Criteria

-

Any of the following is regarded as a criterion for exclusion from the study:

1. Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;

3. Any circumstances under which MRI scans can't be performed;

4. Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;

5. Comatose with NIHSS 1a>1;

6. Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;

7. Suitable for rt-Plasminogen Activator thrombolysis treatment;

8. Receiving medication with possible neuroprotective functions after stroke onset;

9. Currently take steroids therapy;

10. Diagnosed with malignancy within 5 years;

11. Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury;

12. Severe renal function damage (eGFR<30);

13. Concurrent use ciclosporin;

14. A history of hypersensitivity of statins and other severe complication;

15. Child-bearing women ;

16. Patients who are or may be pregnant;

17. Other conditions under which patients not pertinent to attend the study as judged by the investigators.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ESR-14-10028

Identifier Type: -

Identifier Source: org_study_id