Stroke, Acute IschemicPhase 4NCT06083961

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile

A Phase 4 study testing Alirocumab in people with Stroke, Acute Ischemic and PCSK9 Inhibitor, run by Sun U. Kwon at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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 1. the change in lipid profile compared to baseline results 2. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Stroke, Acute Ischemic, PCSK9 Inhibitor
What is being tested?: Alirocumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteSouth Korea
Study dates: 15 Oct 2023to 15 Nov 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-cardioembolic Stroke
Acute Ischemic stroke within 7 days of symptom onset (confirmed by CT or MRI)
Age 19 and above
Significant stenosis associated with atherosclerosis in major intracranial / extracranial vessels.
National Institutes of Health Stroke Scale(NIHSS) score of 15 or less at admission
Patients with the capacity to consent for participation in the clinical trial.

Who cannot join

Presence of high-risk factors for cardioembolism
Risk of ischemic stroke due to thrombosis from other causes
Patients with hemorrhagic stroke, brain tumors, or brain abscesses
Patients unable to take statins or PCSK9 inhibitors
Pre-stroke mRS score of 3 or higher
Severe liver failure (liver enzyme > 3 times the upper normal limit) or renal failure (serum Creatinine > 2mg/dL or estimated glomerular filtration rate < 30 mL/min/1.73m2)

Show all 11Show fewer

Anemia (hemoglobin < 8mg/dL) or thrombocytopenia (platelet count < 100K)
Uncontrolled diabetes not managed by medication or insulin
Pregnant or breastfeeding patients
Patients already receiving PCSK-9 inhibitors
Patients deemed inappropriate for participation in the clinical trial by the investigator for other reasons.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

Asan Medical Center
Seoul, 138-736

Other trials in South Korea

About this study

Official title: The Effect of Early Administration of PCSK9 Inhibitor, Alirocumab to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile, a Single Center Study, Registry Based, Pragmatic, Prospective Trial

the change in lipid profile compared to baseline results
the effects on prognosis of stroke The participants will be given PCSK9 inhibitor right after confirmation of acute ischemic stroke, and the investigators will compare the results to the control group, whom are acute ischemic stroke patients treated with conventional lipid lowering therapy, statin and/or ezetimibe.

Read the detailed description

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.

Conditions: Stroke, Acute Ischemic, PCSK9 Inhibitor
Being tested: Alirocumab
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlirocumabDrug
Also called Praluent
Initial alirocumab, single dose of 300mg, subcutaneous injection

Study groups in NCT06083961
Study group	Role	What they receive
Alirocumab	Experimental	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. Receives: Drug: Alirocumab
Standard of care	No intervention	The control group patients will receive standard and conventional acute ischemic stroke treatment, which includes statin therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

LDL change rate
The change rate of LDL in PCSK9 inhibitor treated group (alirocumab group) compared to standard of care group.
Measured: 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)
Measured: 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).

Secondary outcomes (17)

Change of total cholesterol(TC)
The change of TC during admission and at Outpatient department(OPD) follow up
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202315 Nov 2026

First posted16 Oct 2023
Study start15 Oct 2023 (estimated)
Primary completion15 Oct 2026 (estimated)
Study completion15 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Single center study, Registry based, Pragmatic, Prospective trial
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06083961
Sponsor's protocol ID: PCSK9_001
Status last verified: Oct 2023
First submitted: 12 Sep 2023
Last updated: 16 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
PubMed 15007110
Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8. doi: 10.1001/jama.285.13.1711.
PubMed 11277825
Penson PE, Pirro M, Banach M. LDL-C: lower is better for longer-even at low risk. BMC Med. 2020 Oct 8;18(1):320. doi: 10.1186/s12916-020-01792-7.
PubMed 33032586
Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Quintero K, Roe MT, Sasiela WJ, Tamby JF, Tricoci P, White HD, Zeiher AM; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018 Nov 29;379(22):2097-2107. doi: 10.1056/NEJMoa1801174. Epub 2018 Nov 7.
PubMed 30403574
Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
PubMed 28304224
Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.
PubMed 30586774
Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
PubMed 31504418
Koskinas KC, Windecker S, Pedrazzini G, Mueller C, Cook S, Matter CM, Muller O, Haner J, Gencer B, Crljenica C, Amini P, Deckarm O, Iglesias JF, Raber L, Heg D, Mach F. Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS). J Am Coll Cardiol. 2019 Nov 19;74(20):2452-2462. doi: 10.1016/j.jacc.2019.08.010. Epub 2019 Aug 31.
PubMed 31479722
Leucker TM, Blaha MJ, Jones SR, Vavuranakis MA, Williams MS, Lai H, Schindler TH, Latina J, Schulman SP, Gerstenblith G. Effect of Evolocumab on Atherogenic Lipoproteins During the Peri- and Early Postinfarction Period: A Placebo-Controlled, Randomized Trial. Circulation. 2020 Jul 28;142(4):419-421. doi: 10.1161/CIRCULATIONAHA.120.046320. Epub 2020 Jul 27. No abstract available.
PubMed 32718248
Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
PubMed 35368058
Kim BJ, Kim JS. Ischemic stroke subtype classification: an asian viewpoint. J Stroke. 2014 Jan;16(1):8-17. doi: 10.5853/jos.2014.16.1.8. Epub 2014 Jan 31.
PubMed 24741560
Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.
PubMed 21899409
Hong KS, Bang OY, Park JH, Jung JM, Lee SH, Song TJ, Nam HS, Park HK, Jung KH, Heo SH, Koo J, Yu KH, Park KY, Kim CK, Park HK, Lee J, Lee J, Seo WK. Moderate-Intensity Rosuvastatin Plus Ezetimibe Versus High-Intensity Rosuvastatin for Target Low-Density Lipoprotein Cholesterol Goal Achievement in Patients With Recent Ischemic Stroke: A Randomized Controlled Trial. J Stroke. 2023 May;25(2):242-250. doi: 10.5853/jos.2022.02957. Epub 2023 Apr 11.
PubMed 37032475

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Early Administration of PCSK9 Inhibitor, Alirocumab to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile, a Single Center Study, Registry Based, Pragmatic, Prospective Trial
ClinicalTrials.gov ID: NCT06083961
Acronym / sponsor ID: PCSK9_001
Conditions: Stroke, Acute Ischemic, PCSK9 Inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Sun U. KwonUniversity, hospital or other
Study start: 15 Oct 2023 (estimated)
Primary completion: 15 Oct 2026 (estimated)
Study completion: 15 Nov 2026 (estimated)
First posted: 16 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

the change in lipid profile compared to baseline results
the effects on prognosis of stroke The participants will be given PCSK9 inhibitor right after confirmation of acute ischemic stroke, and the investigators will compare the results to the control group, whom are acute ischemic stroke patients treated with conventional lipid lowering therapy, statin and/or ezetimibe.

Detailed description

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.

The investigators are planning on total 200 patients enrollment (100 treatment group + 100 control group).

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).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Single center study, Registry based, Pragmatic, Prospective trial

Arm	Type	Receives
Alirocumab	Experimental	Drug: AlirocumabThe 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.
Standard of care	No intervention	–The control group patients will receive standard and conventional acute ischemic stroke treatment, which includes statin therapy.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Non-cardioembolic Stroke
Acute Ischemic stroke within 7 days of symptom onset (confirmed by CT or MRI)
Age 19 and above
Significant stenosis associated with atherosclerosis in major intracranial / extracranial vessels.
National Institutes of Health Stroke Scale(NIHSS) score of 15 or less at admission

Key exclusion criteria (11 listed)

Presence of high-risk factors for cardioembolism
Risk of ischemic stroke due to thrombosis from other causes
Patients with hemorrhagic stroke, brain tumors, or brain abscesses
Patients unable to take statins or PCSK9 inhibitors
Pre-stroke mRS score of 3 or higher

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlirocumabAlso: PraluentInitial alirocumab, single dose of 300mg, subcutaneous injection	Drug	Alirocumab

Primary outcome

LDL change rate
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).
The change rate of LDL in PCSK9 inhibitor treated group (alirocumab group) compared to standard of care group.
Achievement rate to target LDL level
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).
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)

17 secondary outcomes

Change of total cholesterol(TC)
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)
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)
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
Time frame: Apolipoprotein-B is collected at day-1, once.
Change of Lipoprotein-A
Time frame: Lipoprotein-A are collected at day-1, once.
The patient's outcome - 1
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
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
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
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
Time frame: The drop of NIHSS score in initial period (72 hours) during admission.
The expansion of stroke lesion
Time frame: The follow up MRI is routinely taken at day-1 or day-2 of hospitalization.
The recurrence rate
Time frame: The event rate until the outpatient follow up date (up to 1 month, day-30).
The rate of complications of statin - 1
Time frame: Laboratory tests for hemoglobin A1c (%) will be done at outpatient follow up date (day-30).
The rate of complications of statin - 2
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
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
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
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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
Background: PubMed 15007110Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
Background: PubMed 11277825Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8. doi: 10.1001/jama.285.13.1711.
Background: PubMed 33032586Penson PE, Pirro M, Banach M. LDL-C: lower is better for longer-even at low risk. BMC Med. 2020 Oct 8;18(1):320. doi: 10.1186/s12916-020-01792-7.
Background: PubMed 30403574Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Quintero K, Roe MT, Sasiela WJ, Tamby JF, Tricoci P, White HD, Zeiher AM; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018 Nov 29;379(22):2097-2107. doi: 10.1056/NEJMoa1801174. Epub 2018 Nov 7.
Background: PubMed 28304224Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
Background: PubMed 30586774Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.
Background: PubMed 31504418Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
Background: PubMed 31479722Koskinas KC, Windecker S, Pedrazzini G, Mueller C, Cook S, Matter CM, Muller O, Haner J, Gencer B, Crljenica C, Amini P, Deckarm O, Iglesias JF, Raber L, Heg D, Mach F. Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS). J Am Coll Cardiol. 2019 Nov 19;74(20):2452-2462. doi: 10.1016/j.jacc.2019.08.010. Epub 2019 Aug 31.
Background: PubMed 32718248Leucker TM, Blaha MJ, Jones SR, Vavuranakis MA, Williams MS, Lai H, Schindler TH, Latina J, Schulman SP, Gerstenblith G. Effect of Evolocumab on Atherogenic Lipoproteins During the Peri- and Early Postinfarction Period: A Placebo-Controlled, Randomized Trial. Circulation. 2020 Jul 28;142(4):419-421. doi: 10.1161/CIRCULATIONAHA.120.046320. Epub 2020 Jul 27. No abstract available.
Background: PubMed 35368058Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
Background: PubMed 24741560Kim BJ, Kim JS. Ischemic stroke subtype classification: an asian viewpoint. J Stroke. 2014 Jan;16(1):8-17. doi: 10.5853/jos.2014.16.1.8. Epub 2014 Jan 31.
Background: PubMed 21899409Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alirocumab in people with Stroke, Acute Ischemic and PCSK9 Inhibitor, run by Sun U. Kwon at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL change rate (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06083961, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.