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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02643784
Other study ID # ESR-14-10028
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received December 16, 2015
Last updated December 28, 2015
Start date December 2015
Est. completion date July 2017

Study information

Verified date December 2015
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke 0-14d No
Secondary Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke 0-14d No
Secondary Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke 0-14d No
Secondary The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group 14-90d No
Secondary The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group 14-90d No
Secondary The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group 0-14d No
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