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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Ischemic

Treatments: Other: Control; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02643784

ESR-14-10028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rosuvastatin

Experimental group

Description:

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).

Treatment:

Other: Control

Drug: Rosuvastatin

Control

No Intervention group

Description:

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