Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke Patients(REPAIRS)

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is randomized, open-lable, parallel-group and comparator-controlled. 456 consecutive patients with acute ischemic stroke admitted within the first 72 hours after onset of symptoms will be studied. Those patients who will be randomly assigned to receive 2 different treatment for the first 3 days of hospitalization(non-statin-therapy group) or to immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients. The total trial will be continued 12 months.

mRS will be investigated at baseline, 3rd month, 12th month ;MMSE and Montreal tests will be investigated at baseline and 12th month. Laboratory data including serum lipids, Fg and hs-CRP.Among these, serum lipids will be tested at baseline, 8th day, 3rd month, 6th month,and 12th month; hs-CRP will be tested at baseline and 8th day, 3rd month; Fg will be tested at baseline, 8th day, 3rd month. Safety will be also assessed by adverse event reports and clinical laboratory data including CK-MB, renal and hepatic function at 3rd month, 6th month,12th month.

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

Details

• Lead Sponsor: Second Affiliated Hospital of Soochow University
• Collaborators: AstraZeneca; National Natural Science Foundation of China; Taicang No.1 People's hospital; Taicang No.1 People’s hospital
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Adults between 35 and 80 years old

3. Anterior circulation ischemic stroke within 72h of large arterial atherosclerosis subtype

4. First attack or without obvious sequelae after previous attacks of stroke(mRS≤1)

5. NIHSS score less than 24 when onset

6. Statin-naive(no statin therapy in the past 3 months)

Exclusion Criteria:

1. Familial hypercholesterolemia

2. Cardiogenic embolism and hemorrhagic transformation

3. Unknown cause and rare cause stroke subtypes

4. On or need to be on anticoagulant therapy

5. Severe hepatic(e.g. active liver disease, ALT or AST over 3 times of ULN), renal, hematopoietic, endocrine, myopathy , mental and cognitive diseases

6. Subjects with thrombolytic therapy

7. Concomitant treatment with ciclosporin

8. Allergy to statins or antiplatelet drugs

9. Planning to have a major operation or carotid ,vertebral angioplasty

10. Pregnancy and poor compliance.