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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic
• Intervention / Treatment: Drug: Rosuvastatin; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Rosuvastatin; Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.; Other Names: RSV; Other: Control; Randomized Treatment Period (Day 1 through Day 14): No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.
No Intervention: Control; Control group(don't take rosuvastatin until 14th day), as directed by the study physician.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke	0-14d
Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke	0-14d
The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group	14-90d
The functional outcome measured by modified Rankin Scale (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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: acute ischemic stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: ESR-14-10028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes