Clinical trial NCT02643784: Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
Official title: Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic
Keywords: acute ischemic stroke
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;
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.

Primary outcomes:
measure: Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
timeFrame: 0-14d
Secondary outcomes:
measure: Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
timeFrame: 0-14d
measure: Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke
timeFrame: 0-14d
measure: The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group
timeFrame: 14-90d
measure: The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group
timeFrame: 14-90d
measure: The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group
timeFrame: 0-14d
Other outcomes:
Locations:
Study officials:
References: