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

NCT02484027 | Unknown Phase 4 DMC

• 1 other identifier: ESR-14-10580
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Infarction, Anterior Cerebral Artery

Keywords

acute ischemic stroke; mRS; rosuvastatin

Outcome Measures

Primary Outcomes (2)

• proportion of patients with poor prognosis(modified Rankin scale>2)

  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)

  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 Outcomes (2)

• the occurrence of vascular events( a composite)

  12th months after onset of stroke

• Change from baseline in cognitive function at 12 months

  12 months

Other Outcomes (9)

• Change from baseline in serum lipids(a composite) at 12 months

  3rd, 8th day and 3 rd, 6th and 12th month

• Change from baseline in hs-CRP level at 3 months

  baseline, 3rd, 6th and 12th month

• Change from baseline in Fg level at 3 months

  3rd month

Study Arms (2)

statin-therapy

EXPERIMENTAL

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

non-statin-therapy

SHAM COMPARATOR

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

Interventions

Rosuvastatin DRUG

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

non-statin-therapy; statin-therapy

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead
• Taicang No.1 People's hospital: collaborator
• AstraZeneca: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Related Publications (11)

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  PMID: 24788967 BACKGROUND

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  PMID: 21372311 BACKGROUND

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MeSH Terms

Conditions

Infarction, Anterior Cerebral Artery; Ischemic Stroke

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chun-Feng Liu, Ph.D,M.D.

  Second Afflilated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Chun-Feng Liu, Ph.D,M.D.

CONTACT

00 86 512 67783307; liucf@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 29, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

CN (1)