Back to resultsExploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke (AIS)
Primary Purpose
Ischemic
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Control
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic focused on measuring acute ischemic stroke
Eligibility Criteria
Inclusion Criteria:
- 45 to 75 years old patients;
- Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
- Time from symptom onset to take the study assigned medication is within 24 hours;
- Statin naïve or discontinued at least 3 month before stroke onset;
- First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
- Moderate neurological deficit with baseline NIHSS scoring from 4-20;
- MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset;
- Consent form signed.
Exclusion Criteria:
-
Any of the following is regarded as a criterion for exclusion from the study:
- Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
- 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;
- Any circumstances under which MRI scans can't be performed;
- Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
- Comatose with NIHSS 1a>1;
- Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;
- Suitable for rt-Plasminogen Activator thrombolysis treatment;
- Receiving medication with possible neuroprotective functions after stroke onset;
- Currently take steroids therapy;
- Diagnosed with malignancy within 5 years;
- Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury;
- Severe renal function damage (eGFR<30);
- Concurrent use ciclosporin;
- A history of hypersensitivity of statins and other severe complication;
- Child-bearing women ;
- Patients who are or may be pregnant;
- Other conditions under which patients not pertinent to attend the study as judged by the investigators.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rosuvastatin
Control
Arm 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).
Control group(don't take rosuvastatin until 14th day), as directed by the study physician.
Outcomes
Primary Outcome Measures
Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Secondary Outcome Measures
Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke
The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group
The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group
The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02643784
Brief Title
Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
Acronym
AIS
Official Title
Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic
Keywords
acute ischemic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group(don't take rosuvastatin until 14th day), as directed by the study physician.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
RSV
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Time Frame
0-14d
Secondary Outcome Measure Information:
Title
Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Time Frame
0-14d
Title
Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke
Time Frame
0-14d
Title
The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group
Time Frame
14-90d
Title
The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group
Time Frame
14-90d
Title
The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group
Time Frame
0-14d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
45 to 75 years old patients;
Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
Time from symptom onset to take the study assigned medication is within 24 hours;
Statin naïve or discontinued at least 3 month before stroke onset;
First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
Moderate neurological deficit with baseline NIHSS scoring from 4-20;
MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset;
Consent form signed.
Exclusion Criteria:
-
Any of the following is regarded as a criterion for exclusion from the study:
Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
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;
Any circumstances under which MRI scans can't be performed;
Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
Comatose with NIHSS 1a>1;
Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;
Suitable for rt-Plasminogen Activator thrombolysis treatment;
Receiving medication with possible neuroprotective functions after stroke onset;
Currently take steroids therapy;
Diagnosed with malignancy within 5 years;
Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury;
Severe renal function damage (eGFR<30);
Concurrent use ciclosporin;
A history of hypersensitivity of statins and other severe complication;
Child-bearing women ;
Patients who are or may be pregnant;
Other conditions under which patients not pertinent to attend the study as judged by the investigators.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
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