Study Stopped
Slow enrollment
The Effects of Very Early Use of Rosuvastatin in Preventing Recurrence of Ischemic Stroke
EUREKA
An Investigator-Sponsored,Double Blind,Placebo-controlled,Randomised,Multi-centre Study to Assess the Effects of Very Early Use of Rosuvastatin in Preventing Recurrence of Ischemic Stroke
1 other identifier
interventional
318
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 stroke
Started Aug 2010
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 20, 2014
November 1, 2014
2.7 years
May 26, 2011
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence Of Newly Developed DWI Lesions
The objective would be to Compare the recurrence rate of ischemic strike by comparing the PRESENCE of newly developed DWI between baseline and after 14 days of treatment.
During 14 days of treatment
Secondary Outcomes (1)
Volume Of DWI Lesions With Percent Improvement Of NIHSS Score
During 14 days of treatment
Study Arms (2)
Rosuvastatin
EXPERIMENTALRosuvastatin 20mg tablet, once daily, for 14 days
Placebo
PLACEBO COMPARATORPlacebo tablet, once daily, for 14 days
Interventions
Rosuvastatin 20mg tablet, once daily, for 14 days
Eligibility Criteria
You may qualify if:
- Male or female over 20 years of age
- Ischemic stroke patients who were undertaken MRI within 48 hrs after onset of symptoms
- Patients underwent baseline MRI (DWI, FLAIR, GRE and MRA)
- Ischemic stroke patients with any degree of stenosis on the relevant artery of atherothrombotic origin appearing on DWI through MRA or CTA
- Statin-naïve (untreated with statin for the past 3 months)
You may not qualify if:
- Hemorrhagic stroke/ history of symptomatic hemorrhagic stroke.
- 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.
- 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.
- 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.
- Life-threatening illness indicating the subject is not expected to survive for at least 2 years.
- Secondary causes of nephrotic syndrome, and/or renal dysfunction (serum creatinine \>2.0 mg/dL \[177 mmol/L\]) at screening.
- Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study.
- Unreliability as a study participant based on the Investigator's knowledge of the subject, such as drug or alcohol abuse.
- 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
- 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.
- 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.
- 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.
- Triglyceride (TG) level of greater than 500 mg/dL at screening.
- LDL level of greater than 190 mg/dL at screening.
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Severance Hospitallead
- AstraZenecacollaborator
Study Sites (27)
Department of Neurology, Hallym University Sacred Heart Hospital
Anyang, South Korea
Department of Neurology Colleage of Medicine Dong-A University
Busan, South Korea
Department of Neurology Pusan National University Hospital
Busan, South Korea
Department of Neurology, College of Medicine Inje University, Paik Hospital
Busan, South Korea
Department of Neurology, Fatima hospital
Changwon, South Korea
Department of Neurology, Samsung Changwon hospital
Changwon, South Korea
Department of Neurology, Dongsan Medical Center, Keimyung University School of Medicine
Daegu, South Korea
Department of Neurology, Yeungnam University School of Medicine
Daegu, South Korea
Department of Neurology Konyang University Hospital
Daejeon, South Korea
Department of Neurology, Chonnam National University Hospital
Gwangju, South Korea
Department of Neurology, Chosun University Hospital
Gwangju, South Korea
Department of Neurology, Inha University Hospital
Incheon, South Korea
Department of Neurology, National health insurance corporation ilsan Hospital
Koyang-shi, South Korea
Department of Neurology, Severance Hospital
Seoul, 120-752, South Korea
Department of Neurology Gangnam Severance Hospital
Seoul, South Korea
Department of Neurology Kyung Hee University East-West Neo Medical Center
Seoul, South Korea
Department of Neurology Seoul National University Hospital
Seoul, South Korea
Department of Neurology St. Mary's Hospital, Catholic University
Seoul, South Korea
Department of Neurology, Ewha Womans University Hospital
Seoul, South Korea
Department of Neurology, Hallym University Medical Center
Seoul, South Korea
Department of Neurology, Korean University Guro hospital
Seoul, South Korea
Department of Neurology, Kyung Hee University, College of Medicine
Seoul, South Korea
Department of Neurology, National Medical Center
Seoul, South Korea
Department of Neurology, Samsung Medical Center
Seoul, South Korea
Department of Neurology, University of Ulsan,Asan Medical Center
Seoul, South Korea
Department of Neurology,Sanggye Paik Hospital, Inje University College of Medicine
Seoul, South Korea
Department of Neurology, Wonju Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Hoe Heo, MD., Ph. D
Department of Neurology, Severance Hospital, 250 Seongsan-no,Seodaemun-gu,Seoul,120-752, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ji Hoe Heo, Professor, Department of Neurology, Yonsei University College of Medicine
Study Record Dates
First Submitted
May 26, 2011
First Posted
June 2, 2011
Study Start
August 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 20, 2014
Record last verified: 2014-11