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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Rosuvastatin Calcium

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;

2. Hemorrhagic transformation or intracranial hemorrhage on baseline MRI. MRI performed between 12-48 hours after the onset, if MRI provides evidences which met with the exclusion criteria, the patients will be excluded from the study;

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.