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

Ischemic Clinical Trial

— AIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02643784
• Other study ID #: ESR-14-10028
• 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

• Ischemia
• Ischemic

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