Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02484027
Status:
UNKNOWN
Last Update Posted:
2015-06-29
First Post:
2015-06-17
Brief Title:
Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke PatientsREPAIRS
Sponsor:
Second Affiliated Hospital of Soochow University
Organization:
Second Affiliated Hospital of Soochow University
Study Overview
Official Title:
Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke Patients
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIRS
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 hospitalizationnon-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-CRPAmong these serum lipids will be tested at baseline 8th day 3rd month 6th monthand 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 month12th month
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-CRPAmong these serum lipids will be tested at baseline 8th day 3rd month 6th monthand 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 month12th month
Detailed Description:
This study is randomized open-lable parallel-group and comparator-controlled456 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 hospitalizationnon-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 monthsSubject 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 11 schedule
According to the previous post hoc analysis and SPARCL analysis results the mRS event rate mRS2 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 Pearsons chi-squared test with a two-sided significance level of 005 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-CRPAmong these serum lipids will be tested at baseline 8th day and 3rd month 6th month12th 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 month12th month
Primary endpoint is the proportion of poor prognosismodified Rankin scores2 at 3 and 12 months post discharge mRS scores2 is defined as poor prognosis And mRS scores2 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 strokeTIA 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 patients 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
According to the previous post hoc analysis and SPARCL analysis results the mRS event rate mRS2 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 Pearsons chi-squared test with a two-sided significance level of 005 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-CRPAmong these serum lipids will be tested at baseline 8th day and 3rd month 6th month12th 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 month12th month
Primary endpoint is the proportion of poor prognosismodified Rankin scores2 at 3 and 12 months post discharge mRS scores2 is defined as poor prognosis And mRS scores2 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 strokeTIA 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None