Overview

The Effects of Very Early Use of Rosuvastatin in Preventing Recurrence of Ischemic Stroke

Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
Summary
It is anticipated that 548 subjects will be recruited from approximately 27 centres in South Korea. This is an investigator-sponsored, double-blind, placebo-controlled, randomized, multi-centre study to assess the effects of rosuvastatin 20 mg compared to placebo in acute ischemic stroke patients, with the first dose within 18 hours after baseline MRI and continued treatment for 14 days. Subjects will be male or female, over 20 years, with diagnosis of acute ischemic stroke with baseline MRI, and who are either statin-naïve or untreated with statin for the previous 3 months. The objective would be to compare the recurrence rate of ischemic stroke by comparing the imaging parameters during 14 days of treatment and clinical improvement as defined by percent improvement based on NIHSS scores measurements at baseline, 5 days and 14 days of treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Severance Hospital
Collaborator:
AstraZeneca
Treatments:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

1. Male or female over 20 years of age

2. Ischemic stroke patients who were undertaken MRI within 48 hrs after onset of symptoms

3. Patients underwent baseline MRI (DWI, FLAIR, GRE and MRA)

4. Ischemic stroke patients with any degree of stenosis on the relevant artery of
atherothrombotic origin appearing on DWI through MRA or CTA

5. Statin-naïve (untreated with statin for the past 3 months)

Exclusion Criteria:

1. Hemorrhagic stroke/ history of symptomatic hemorrhagic stroke.

2. Presence of high-risk potential cardiac sources of embolism based on the TOAST
classification or other determined etiology of stroke at the time of enrollment.

3. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine
dysfunction which, in the judgment of the Investigator, may affect the subject's
ability to complete the study.

4. History of malignancy, except in subjects who have been disease-free >5 years or whose
only malignancy has been basal or squamous cell skin carcinoma.

5. Life-threatening illness indicating the subject is not expected to survive for at
least 2 years.

6. Secondary causes of nephrotic syndrome, and/or renal dysfunction (serum creatinine
>2.0 mg/dL [177 mmol/L]) at screening.

7. Significant medical or psychological condition that, in the opinion of the
Investigator, would compromise the subject's safety or successful participation in the
study.

8. Unreliability as a study participant based on the Investigator's knowledge of the
subject, such as drug or alcohol abuse.

9. Pregnant or lactating women or women of childbearing potential who were not protected
from pregnancy by an accepted method of contraception, such as the oral contraceptive
pill, an intrauterine device or surgical sterilization

10. Uncontrolled hypertension defined as either a resting diastolic blood pressure of >110
mmHg or a resting systolic blood pressure of >185 mmHg recorded at screening despite
blood pressure lowering therapy.

11. Clinically significant heart disease which, in the opinion of the Principal
Investigator (or designee), is likely to require coronary bypass surgery, cardiac
transplantation, surgical repair and/or replacement during the course of the study.

12. Subjects who have symptoms consistent with moderate or greater severity of] congestive
heart failure (CHF) (New York Heart Association [NYHA] Class III or IV), or whose most
recent determination of left ventricular ejection fraction (LVEF) is <0.35.

13. Triglyceride (TG) level of greater than 500 mg/dL at screening.

14. LDL level of greater than 190 mg/dL at screening.

15. Creatine kinase (CK) >3 times the upper limit of the normal (ULN) range at screening,
because of the potential of statins to cause muscle abnormalities.

16. Active liver disease or hepatic dysfunction, as determined by aspartate
aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) or bilirubin
levels >3 x ULN at screening, because of the potential of statins to cause
disturbances in liver function.

17. Uncontrolled primary hypothyroidism (defined as thyroid stimulating hormone [TSH] >1.5
x ULN.

18. Modified Rankin scale score 4 to 6 before stroke.

19. Participation in any investigational clinical study for drug or device within 30 days
prior to study entry or expectation to participate in any other investigational
clinical study for drug or device during the course of this study.

20. Patients who may need conventional angiography or intervention within 14 days after
enrollment.

21. Known serious hypersensitivity reactions to HMG-CoA reductase inhibitors.

22. Use of any medication listed in the Prohibited Medications Section

23. History of myopathy.

24. Patients who has Galactose intolerance,lactose intolerance,Glucose- Galactose
absorption problem.