Infarction, Anterior Cerebral Artery Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03679364 -
An Observational Registry Study of LUOTAI in Patients With Acute Ischemic Stroke in Vietnam
|
||
| Recruiting |
NCT04093336 -
Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
|
Phase 1/Phase 2 |