A Phase 4 interventional study of Alirocumab in Stroke, Acute Ischemic and PCSK9 Inhibitor, sponsored by Sun U. Kwon. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Sun U. Kwon · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to test the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors) in acute ischemic stroke patients associated with atherosclerosis by investigating
This clinical trial will be recommended to patients aged 19 and older who are admitted with ischemic stroke accompanied by atherosclerosis of large arteries, rather than cardiac embolism. Upon confirmation of ischemic stroke through CT and MRI in the emergency room, the patient will be provided with a detailed explanation of the future treatment plan and the purpose of this study.
Depending on the day of the week, the patient will be randomly assigned to the treatment group (alirocumab + high-dose statin group) and the control group (high-dose statin group) in a 1:1 ratio.
For those in the treatment group, alirocumab (brand name: Praluent Pen) 300mg will be administered as a single dose. Both the treatment and control groups will receive standard diagnostic tests and treatments as conventional stroke patients unrelated to the clinical trial. Blood samples collected for testing will be promptly discarded by the hospital's diagnostic laboratory. Both groups will have outpatient visits one month after discharge.
The investigators are planning on total 200 patients enrollment (100 treatment group + 100 control group).
For categorical variables, frequency and percentage will be provided, and for continous variables, mean and standard deviation will be provided. All statistical tests used for analysis will be two-tailed. Statistical significance will be tested at a 5% significance level. If necessary, two-sided 95% confidence intervals will be provided.
In the analysis of the entire registered patient population, not only univariate analysis but also multivariate analysis (Cox proportional hazard regression model) will be conducted to adjust for other factors.
Detailed techniques for data summary and statistical analysis from the data collected in this clinical trial will be specified in the Statistical Analysis Plan (SAP).
When sided effects or adverse events occur, the Principal Investigator is required to promptly report safety information, which includes occurrences of serious adverse events and drug-related adverse reactions, to the Institutional Review Board (IRB) of the trial institution within the timeframe specified in the trial institution's standard operating procedures during the trial period. Upon becoming aware of all occurrences of serious adverse events and special situations, regardless of their causality with the investigational product, the Principal Investigator will complete a 'Serious Adverse Event Report/Adverse Event of Special Situation' within 24 hours.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Sun U. Kwon as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment group patients will receive an additional PCSK9 inhibitor (alirocumab 300mg once) at emergency departement in addition to statin therapy, which is conventional medication given for acute ischemic stroke.
Drug: Alirocumab
The control group patients will receive standard and conventional acute ischemic stroke treatment, which includes statin therapy.
Initial alirocumab, single dose of 300mg, subcutaneous injection
Also known as: Praluent
LDL change rate
The change rate of LDL in PCSK9 inhibitor treated group (alirocumab group) compared to standard of care group.
Time frame: LDL level at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
Achievement rate to target LDL level
The investigators intend to use 3 different criteria - 1. LDL under 70mg/dl 2. LDL under 55mg/dL 3. LDL decrement over 50% compared to baseline (day0 LDL)
Time frame: LDL target achievement rate at day-1 of hospitalization, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
Change of total cholesterol(TC)
The change of TC during admission and at Outpatient department(OPD) follow up
Time frame: TC levels are checked all together with LDL level, which is at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
Change triglyceridTG)
The change of TG during admission and at Outpatient department(OPD) follow up
Time frame: TG levels are checked all together with LDL level, which is at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
Change of High density lipoprotein(HDL)
The change of HDL during admission and at Outpatient department(OPD) follow up
Time frame: HDL levels are checked all together with LDL level, which is at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
Change of Apolipoprotein-B
The change of Apolipoprotein-B during admission and at Outpatient department(OPD) follow up
Time frame: Apolipoprotein-B is collected at day-1, once.
Change of Lipoprotein-A
The change of Lipoprotein-A during admission and at Outpatient department(OPD) follow up
Time frame: Lipoprotein-A are collected at day-1, once.
The patient's outcome - 1
Patients' modified Rankin score (mRS) at discharge date and Outpatient department(OPD) follow up date. mRS score ranges from 0 to 6, in which 0 means having no symptoms and 6 means expired.
Time frame: mRS is calculated when patients are discharged from neurology department(normally day-5 to day-7), and when patients come to outpatient department (day-30).
The patient's outcome - 2
Patients' National Institutes of Health Stroke Scale (NIHSS) score at discharge date and Outpatient department(OPD) follow up date. NIHSS ranges from 0 to maximum 42, in which 0 means having no symptoms.
Time frame: NIHSS score is calculated when patients are discharged from neurology department(normally day-5 to day-7), and when patients come to outpatient department (day-30).
The difference between admission and discharge - 1
The difference between modified Rankin Scale (mRS) at admission and discharge state. The difference are then calculated to see whether the patients' status have improved or worsened. mRS score ranges from 0 to 6, in which 0 means having no symptoms and 6 means expired.
Time frame: mRS is assessed when patients are admitted(day-0), and when patients are discharged(normally day-5 to day-7).
The difference between admission and discharge - 2
The difference between National Institutes of Health Stroke Scale (NIHSS) score at admission and discharge state. The difference are then calculated to see whether the patients' status have improved or worsened. NIHSS ranges from 0 to maximum 42, in which 0 means having no symptoms.
Time frame: NIHSS score is assessed when patients are admitted(day-0), and when patients are discharged(normally day-5 to day-7).
Early neurological deterioration
Whether the National Institutes of Health Stroke Scale (NIHSS) score of the patient drops by 2 or more. NIHSS ranges from 0 to maximum 42, in which 0 means having no symptoms.
Time frame: The drop of NIHSS score in initial period (72 hours) during admission.
The expansion of stroke lesion
The increasement of size and territories of infarction, or hemorrhagic transformation at follow up MRI.
Time frame: The follow up MRI is routinely taken at day-1 or day-2 of hospitalization.
The recurrence rate
The rate of cardiovascular / cerebrovascular events during the follow up period
Time frame: The event rate until the outpatient follow up date (up to 1 month, day-30).
The rate of complications of statin - 1
The rate of complications or side effects by checking hemoglobin A1c.
Time frame: Laboratory tests for hemoglobin A1c (%) will be done at outpatient follow up date (day-30).
The rate of complications of statin - 2
The rate of complications or side effects by checking Liver function test (LFT) along with presence of symptoms.
Time frame: Laboratory tests for alanine transaminase (ALT, IU/L) and investigations of possible complication symptoms (abdominal pain or tenderness, fatigue, nausea/vomiting, etc) will be done at outpatient follow up date (day-30).
The rate of complications of statin - 3
The rate of complications or side effects by checking Liver function test (LFT) along with presence of symptoms.
Time frame: Laboratory tests for aspartate transaminase (AST, IU/L) and investigations of possible complication symptoms (abdominal pain or tenderness, fatigue, nausea/vomiting, etc) will be done at outpatient follow up date (day-30).
The rate of complications of statin -4
The rate of complications or side effects by checking muscle enzyme lab along with presence of symptoms.
Time frame: Laboratory tests (myoglobin, ng/mL) and investigations of possible complication symptoms (muscle pain or fatigue, tenderness) will be done at outpatient follow up date (day-30).
The rate of complications of statin -5
The rate of complications or side effects by checking muscle enzyme lab along with presence of symptoms.
Time frame: Laboratory tests (creatine kinase, IU/L) and investigations of possible complication symptoms (muscle pain or fatigue, tenderness) will be done at outpatient follow up date (day-30).
Plan to share: No
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