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

Phase 4

• Conditions: Ischemic
• Interventions: Drug: Rosuvastatin; Other: Control

• Registration Number: NCT02643784
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-28
• Last Update Submitted: 2015-12-28
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Control	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).
Rosuvastatin	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).

Primary Outcome Measures

Name	Time	Method
Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke	0-14d

Secondary Outcome Measures

Name	Time	Method
Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke	0-14d
The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group	14-90d
The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group	14-90d
The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group	0-14d
Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke	0-14d