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

June 24, 2015 updated by: Chun-Feng Liu, Second Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is randomized, open-lable, parallel-group and comparator-controlled.456 consecutive patients with anterior circulation ischemic stroke within 72h from 2 participating hospitals are enrolled into the study. Those patients who will be randomly assigned to receive 2 different treatments 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.Subject eligibility will be established before treatment randomization. A random number table will be generated using a computerized procedure and subjects will be randomized strictly sequentially as they are eligible for randomization. The randomization procedure will be done like this. The random number will be divided by 2. And if the remainder is 1, the subject will be assigned to intensive rosuvastatin group. Correspondingly, if the remainder is 0, the subject will be assigned to the non-rosuvastatin group. Subjects will be randomized on a 1:1 schedule.

According to the previous post hoc analysis and SPARCL analysis results, the mRS event rate (mRS>2) at 90 days among statin-naïve patients before admission is 42% without statin treatment in the first 3 days of admission versus 28% with statin immediately used since admission. Previous studies showed there is benefit with statin treatment in the earlier period of acute ischemic stroke, so the data from SPARCL reserved conservatively because the patients within 6 months of stroke onset were enrolled. It is based on these reported event rates, a sample size of 182 patients per group will have 80% power to detect a rate difference of 14%, assuming a null rate difference of zero and using Pearson's chi-squared test with a two-sided significance level of 0.05. With an estimated 20% rate of dropping out from the study, a total of 456 patients will have to be randomized (228 in each group) for this study.

Medical histories were obtained from all subjects before enrollment. Patients are followed by 1 year. mRS will be investigated at baseline, 3rd month, 12th month ;MMSE and Montreal tests will be investigated at baseline and 12th month. Laboratory data include serum lipids, Fg and hs-CRP.Among these, serum lipids will be tested at baseline, 8th day and 3rd month, 6th month,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.

Primary endpoint is the proportion of poor prognosis(modified Rankin scores>2) at 3 and 12 months post discharge. mRS scores>2 is defined as poor prognosis. And mRS scores≤2 scores were defined as good prognosis. Primary endpoint is the comparison of percentage of poor prognosis between two groups. Second endpoints include change from baseline in serum lipid, Fg and hs-CRP levels at 8th day, 3rd month, 6th month and 12th month after randomization. The incidence of vascular endpoint events including all-cause mortality, any event of recurrent ischemic stroke/TIA, hemorrhagic stroke, myocardial infarction and angina, and other noncerebral ischemia or hemorrhage. And change from admission in MMSE and Montreal scores of all subjects at 12th month.

Researchers who are responsible for evaluation of mRS, NIHSS scores, MMSE and Montreal scores will receive centralized training and be specialized. Specialized doctors follow-up the subjects with no knowledge of the statin therapies for the patients. Every month a meeting will be held to know if there are problems and to solve them.

Two special doctors in each center are responsible for follow-up visits. Patients will be asked to bring all empty packages to the clinic at each visit. The patient's compliance will be assessed by the investigator and recorded in the CRF. A pill count should be done at a patient level and recorded in the CRF and a dispensing log by the study site personnel.

Study Type

Interventional

Enrollment (Anticipated)

456

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chun-Feng Liu, Ph.D,M.D.
  • Phone Number: 00 86 512 67783307
  • Email: liucf@suda.edu.cn

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Department of Neurology, Second Affiliated Hospital of Soochow University
        • Contact:
          • Chun-Feng Liu, Ph.D, M.D.
          • Phone Number: 00 86 512 67783307
          • Email: 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3rd month after onset of stroke
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.
12th month after onset of stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12th months after onset of stroke
Change from baseline in cognitive function at 12 months
Time Frame: 12 months
Mini-Mental State Examination and Montreal congnitive assessment
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3rd, 8th day and 3 rd, 6th and 12th month
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
baseline, 3rd, 6th and 12th month
Change from baseline in Fg level at 3 months
Time Frame: 3rd month
Fg means fibrinogen
3rd month
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.
3rd month
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.
12th month
Incidence of renal dysfunction
Time Frame: 3rd month
It includes elevation of serum creatinine levels and renal failure.
3rd month
Incidence of renal dysfunction
Time Frame: 12th month
It includes elevation of serum creatinine levels and renal failure.
12th month
Incidence of elevation of serum CK levels
Time Frame: 3rd month
CK means creatine kinase
3rd month
Incidence of elevation of serum CK levels
Time Frame: 12th month
CK means creatine kinase
12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Collaborators

National Natural Science Foundation of China
AstraZeneca
Taicang No.1 People's hospital

Investigators

  • Study Chair: Chun-Feng Liu, Ph.D,M.D., Second Afflilated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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