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Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke Patients(REPAIRS) (REPAIRS)

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ClinicalTrials.gov Identifier: NCT02484027
Recruitment Status : Not yet recruiting
First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborators:
Taicang No.1 People’s hospital
AstraZeneca
National Natural Science Foundation of China
Information provided by (Responsible Party):
Chun-Feng Liu, Second Affiliated Hospital of Soochow University

Brief Summary:

This study is randomized, open-lable, parallel-group and comparator-controlled. 456 consecutive patients with acute ischemic stroke admitted within the first 72 hours after onset of symptoms will be studied. Those patients who will be randomly assigned to receive 2 different treatment for the first 3 days of hospitalization(non-statin-therapy group) or to immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients. The total trial will be continued 12 months.

mRS will be investigated at baseline, 3rd month, 12th month ;MMSE and Montreal tests will be investigated at baseline and 12th month. Laboratory data including serum lipids, Fg and hs-CRP.Among these, serum lipids will be tested at baseline, 8th day, 3rd month, 6th month,and 12th month; hs-CRP will be tested at baseline and 8th day, 3rd month; Fg will be tested at baseline, 8th day, 3rd month. Safety will be also assessed by adverse event reports and clinical laboratory data including CK-MB, renal and hepatic function at 3rd month, 6th month,12th month.


Condition or disease Intervention/treatment Phase
Infarction, Anterior Cerebral Artery Drug: Rosuvastatin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke Patients
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: statin-therapy
Rosuvastatin orally at a dose of 20mg daily is assigned to patients immediately for the first 3 days of hospitalization. From the fourth day onward, rosuvastatin 10 mg daily will be administered for 1 year.
Drug: Rosuvastatin
Patients will be randomly assigned to receive 2 different therapies for the first 3 days of hospitalization: no statins (non-statin-therapy group) or to immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients for 1 year
Sham Comparator: non-statin-therapy
No statins is assigned to patients for the first 3 days of hospitalization. From the fourth day onward, rosuvastatin 10 mg daily will be administered for 1 year.
Drug: Rosuvastatin
Patients will be randomly assigned to receive 2 different therapies for the first 3 days of hospitalization: no statins (non-statin-therapy group) or to immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients for 1 year



Primary Outcome Measures :
  1. proportion of patients with poor prognosis(modified Rankin scale>2) [ Time Frame: 3rd month after onset of stroke ]
    A commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability, and it has become the most widely used clinical outcome measure for stroke clinical trials.mRS≤2 is defined as a good functional outcome, and mRS>2 is defined as a poor functional outcome.

  2. proportion of patients with poor prognosis(modified Rankin scale>2) [ Time Frame: 12th month after onset of stroke ]
    A commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability, and it has become the most widely used clinical outcome measure for stroke clinical trials.mRS≤2 is defined as a good functional outcome, and mRS>2 is defined as a poor functional outcome.


Secondary Outcome Measures :
  1. the occurrence of vascular events( a composite) [ Time Frame: 12th months after onset of stroke ]
    It includes all-cause mortality, any event of recurrent ischemic stroke/TIA, hemorrhagic stroke, myocardial infarction and angina, and other noncerebral ischemia or hemorrhage.

  2. Change from baseline in cognitive function at 12 months [ Time Frame: 12 months ]
    Mini-Mental State Examination and Montreal congnitive assessment


Other Outcome Measures:
  1. Change from baseline in serum lipids(a composite) at 12 months [ Time Frame: 3rd, 8th day and 3 rd, 6th and 12th month ]
    It includes cholesterol, low density lipoprotein and high density lipoprotein It includes cholesterol, triglycerides, high density lipoprotein, low density lipoprotein, hs-CRP and fibrinogen levels

  2. Change from baseline in hs-CRP level at 3 months [ Time Frame: baseline, 3rd, 6th and 12th month ]
    hs-CRP means hyper sensitive C-reactive protein

  3. Change from baseline in Fg level at 3 months [ Time Frame: 3rd month ]
    Fg means fibrinogen

  4. Incidence of abnormal hepatic function(a composite) [ Time Frame: 3rd month ]
    It includes elevation of hepatic enzymes(alanine aminotransferase and aspartate aminotransferase), jaundice, and hepatic failure.

  5. Incidence of abnormal hepatic function(a composite) [ Time Frame: 12th month ]
    It includes elevation of hepatic enzymes(alanine aminotransferase and aspartate aminotransferase), jaundice, and hepatic failure.

  6. Incidence of renal dysfunction [ Time Frame: 3rd month ]
    It includes elevation of serum creatinine levels and renal failure.

  7. Incidence of renal dysfunction [ Time Frame: 12th month ]
    It includes elevation of serum creatinine levels and renal failure.

  8. Incidence of elevation of serum CK levels [ Time Frame: 3rd month ]
    CK means creatine kinase

  9. Incidence of elevation of serum CK levels [ Time Frame: 12th month ]
    CK means creatine kinase



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Adults between 35 and 80 years old
  3. Anterior circulation ischemic stroke within 72h of large arterial atherosclerosis subtype
  4. First attack or without obvious sequelae after previous attacks of stroke(mRS≤1)
  5. NIHSS score less than 24 when onset
  6. Statin-naive(no statin therapy in the past 3 months)

Exclusion Criteria:

  1. Familial hypercholesterolemia
  2. Cardiogenic embolism and hemorrhagic transformation
  3. Unknown cause and rare cause stroke subtypes
  4. On or need to be on anticoagulant therapy
  5. Severe hepatic(e.g. active liver disease, ALT or AST over 3 times of ULN), renal, hematopoietic, endocrine, myopathy , mental and cognitive diseases
  6. Subjects with thrombolytic therapy
  7. Concomitant treatment with ciclosporin
  8. Allergy to statins or antiplatelet drugs
  9. Planning to have a major operation or carotid ,vertebral angioplasty
  10. Pregnancy and poor compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484027


Contacts
Contact: Chun-Feng Liu, Ph.D,M.D. 00 86 512 67783307 liucf@suda.edu.cn

Locations
China, Jiangsu
Department of Neurology, Second Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215004
Contact: Chun-Feng Liu, Ph.D, M.D.    00 86 512 67783307    liucf@suda.edu.cn   
Principal Investigator: Yong-Jun Cao, Ph.D, M.D.         
Principal Investigator: Wan-Qing Zhai, M.D         
Sub-Investigator: Xia Zhang, M.D.         
Sponsors and Collaborators
Second Affiliated Hospital of Soochow University
Taicang No.1 People’s hospital
AstraZeneca
National Natural Science Foundation of China
Investigators
Study Chair: Chun-Feng Liu, Ph.D,M.D. Second Afflilated Hospital of Soochow University

Publications:

Responsible Party: Chun-Feng Liu, Associate Dean, Second Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02484027     History of Changes
Other Study ID Numbers: ESR-14-10580
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Chun-Feng Liu, Second Affiliated Hospital of Soochow University:
acute ischemic stroke
mRS
rosuvastatin

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Infarction
Infarction, Anterior Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors