Intracranial AtherosclerosisPhase 2TOPICAL-MRINCT05001984
Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis
A Phase 2 study testing Alirocumab in people with Intracranial Atherosclerosis and Acute Ischemic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke from intracranial atherosclerosis taking lipid lowering therapy. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Intracranial Atherosclerosis, Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
- 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
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 15 Apr 2025
- Phase
- Phase 2
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) score of 1-15
- Ischemic lesions on diffuse-weighted imaging located in the territory of symptomatic intracranial atherosclerosis (ICAS).
- Symptomatic ICAS (above 30%) at the M1 or M2 of the middle cerebral artery, basilar artery or at the intracranial portion of the internal carotid artery or vertebral artery.
- Serum LDL-C ≥70 mg/dL for subjects on lipid-lowering therapies (such as a statin and/or ezetimibe) or LDL-C ≥100 mg/dL for subjects without lipid-lowering therapies.
- Ability to randomize within 7 days of time last known free of new ischemic symptoms.
- Ability to receive alirocumab or statin treatment within 7 days of stroke onset.
- Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
- Pre-stroke modified Rankin Scale (mRS)≦2
Who cannot join
- Age <20 years.
- Judged by clinical physician.
- After endovascular intervention or endarterectomy for the symptomatic ICAS.
- Patients with more than 50% stenosis of extra-cranial arteries the relevant arteries on magnetic resonance angiography (MRA), including extra-cranial carotid artery or vertebral arteries.
- Patients with high risk of cardioembolic source, such as atrial fibrillation, acute myocardial infarction, severe heart failure or valvular heart disease.
- Other determined stroke etiology, such as vasculitis, shock, antiphospholipid antibody syndrome, arterial dissection, CADASIL and etc.
Show all 18Show fewer
- Qualifying ischemic event induced by angiography or surgery.
- Severe non-cardiovascular comorbidity with life expectancy <6 months.
- Contraindication or allergy to alirocumab or Gadolinium
- Severe renal (serum creatinine >2 mg/dL) or calculated glomerular filtration rate <30 mL/min/ 1.73 m2 by estimated glomerular filtration rate (eGFR) using Cockcroft Gault methodology.
- Hepatic insufficiency (INR>1.2; ALT>40 U/L or any resultant complication, such as variceal bleeding, encephalopathy, or jaundice)
- Hemostatic disorder or systemic bleeding in the past 3 months
- Current thrombocytopenia (platelet count <100 x109/L) or leukopenia (<2 x109/L)
- Anemia（<10 mg/dL）
- History of drug-induced hematologic or hepatic abnormalities
- History of malignancy that required surgery, radiation therapy or systemic therapy.
- Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use effective contraception.
- Other neurological conditions that would complicate assessment of outcomes during follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis - a Prospective, Randomized, Open-label, Blinded End-point Study with High-resolution MR Vessel Wall Imaging
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke from intracranial atherosclerosis taking lipid lowering therapy.
Read the detailed description
In this trial, we will conduct a prospective, randomized, open-label, blinded end-point study using high-resolution MRI in patients with acute ischemic stroke from intracranial atherosclerosis to evaluate the efficacy and safety of alirocumab. We hypothesis that additional alirocumab treatment on a background of statin therapy could result in greater stabilization of intracranial plaque and regression of arterial stenosis.
- Being tested
- Alirocumab
- Keywords
- Intracranial Atherosclerosis, Acute Ischemic Stroke, PCSK9 inhibitor
- Medical subject headings
- Intracranial Arteriosclerosis, 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
Alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | In addition to high-intensity statin and antiplatelet treatment, patients will receive treatment of alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks Receives: Drug: Alirocumab |
| Control group | No intervention | Patient will have high-intensity statin and antiplatelet treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of intracranial atherosclerotic plaque: stenosis degree
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as stenosis degree.
The degree of stenosis was calculated as: (1-lumen area of stenotic lesion/reference lumen area)×100%.
Measured: 26 weeks
The changes of intracranial atherosclerotic plaque: percent atheroma volume
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as percent atheroma volume (PAV).
The PAV was calculated using the following equation:
PAV = Σ(EEM area - Lumen area) / ΣEEM area × 100, where EEM area is the cross-sectional area of the external elastic membrane and Lumen area is the cross-sectional area of the lumen.
Measured: 26 weeks
The changes of intracranial atherosclerotic plaque: enhancement volume
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as enhancement volume.
The enhancement volume was measured as post-contrast plaque enhancement for intracranial arteries and intraplaque hemorrhage.
Measured: 26 weeks
Secondary outcomes (8)
Percentage of patients with major cardiovascular events
Defined as the composite of cardiovascular death, myocardial infarction, transient ischemic attack, ischemic stroke and hemorrhagic stroke.
Measured: 26 weeks
Percentage of patients with myocardial infarction
patients with myocardial infarction
Measured: 26 weeks
Percentage of patients with cardiovascular death
patients with cardiovascular death
Measured: 26 weeks
Percentage of patients with stroke
Include transient ischemic attack, ischemic and hemorrhagic stroke
Measured: 26 weeks
Percentage of patients with ischemic stroke or transient ischemic attack.
Percentage of patients with ischemic stroke or transient ischemic attack.
Measured: 26 weeks
Percentage of patients with new ischemic lesions
Defined as new ischemic lesions in the territory of ICAS between 2 MRIs
Measured: 26 weeks
Percentage of patients with favorable functional recovery
Defined as a mRS ≦2 mRS. The Modified Rankin Scale (mRS) runs from 0-6, running from perfect health without symptoms(score 0) to death(score 6).
Measured: 3 months
Changes in serum biomarkers
Include liver function tests, HbA1c and lipid profiles.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Aug 2021
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, open-label, blinded end-point study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University
- Responsible party
- Sponsor
- Investigators
- Yenchu Huang, MD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001984
- Sponsor's protocol ID
- TOPICAL-MRI
- Other IDs
- MOST 110-2314-B-182A-072
- Acronym
- TOPICAL-MRI
- Status last verified
- Feb 2025
- First submitted
- 22 Jul 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
PubMed 24135208Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
PubMed 24481975Hurford R, Wolters FJ, Li L, Lau KK, Kuker W, Rothwell PM; Oxford Vascular Study Phenotyped Cohort. Prevalence, predictors, and prognosis of symptomatic intracranial stenosis in patients with transient ischaemic attack or minor stroke: a population-based cohort study. Lancet Neurol. 2020 May;19(5):413-421. doi: 10.1016/S1474-4422(20)30079-X.
PubMed 32333899Gao S, Wang YJ, Xu AD, Li YS, Wang DZ. Chinese ischemic stroke subclassification. Front Neurol. 2011 Feb 15;2:6. doi: 10.3389/fneur.2011.00006. eCollection 2011.
PubMed 21427797Xu W. High-resolution MRI of intracranial large artery diseases: how to use it in clinical practice? Stroke Vasc Neurol. 2019 Jun 20;4(2):102-104. doi: 10.1136/svn-2018-000210. eCollection 2019 Jul.
PubMed 31338221Xu WH, Li ML, Gao S, Ni J, Yao M, Zhou LX, Peng B, Feng F, Jin ZY, Cui LY. Middle cerebral artery intraplaque hemorrhage: prevalence and clinical relevance. Ann Neurol. 2012 Feb;71(2):195-8. doi: 10.1002/ana.22626.
PubMed 22367991Petrone L, Nannoni S, Del Bene A, Palumbo V, Inzitari D. Branch Atheromatous Disease: A Clinically Meaningful, Yet Unproven Concept. Cerebrovasc Dis. 2016;41(1-2):87-95. doi: 10.1159/000442577. Epub 2015 Dec 16.
PubMed 26671513Yamamoto Y, Ohara T, Hamanaka M, Hosomi A, Tamura A, Akiguchi I. Characteristics of intracranial branch atheromatous disease and its association with progressive motor deficits. J Neurol Sci. 2011 May 15;304(1-2):78-82. doi: 10.1016/j.jns.2011.02.006. Epub 2011 Mar 13.
PubMed 21402390Kim JS, Yoon Y. Single subcortical infarction associated with parental arterial disease: important yet neglected sub-type of atherothrombotic stroke. Int J Stroke. 2013 Apr;8(3):197-203. doi: 10.1111/j.1747-4949.2012.00816.x. Epub 2012 May 9.
PubMed 22568537Liu D, Liu J, Cai Y, Wong KSL, Liu L. Is the future of symptomatic intracranial atherosclerotic stenosis management promising? J Neurol Neurosurg Psychiatry. 2020 Feb;91(2):122-124. doi: 10.1136/jnnp-2019-321564. No abstract available.
PubMed 31919104Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
PubMed 29766750Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
PubMed 23803136Kim D, Park JM, Kang K, Cho YJ, Hong KS, Lee KB, Park TH, Lee SJ, Kim JG, Han MK, Kim BJ, Lee J, Cha JK, Kim DH, Nah HW, Kim DE, Ryu WS, Kim JT, Choi KH, Choi JC, Lee BC, Yu KH, Oh MS, Kim WJ, Kwon JH, Shin DI, Sohn SI, Hong JH, Lee JS, Lee J, Gorelick PB, Bae HJ. Dual Versus Mono Antiplatelet Therapy in Large Atherosclerotic Stroke. Stroke. 2019 May;50(5):1184-1192. doi: 10.1161/STROKEAHA.119.024786.
PubMed 30932785Chimowitz 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 21899409Weinberger J. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. Curr Cardiol Rep. 2006 Feb;8(1):7. No abstract available.
PubMed 16507227
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis - a Prospective, Randomized, Open-label, Blinded End-point Study with High-resolution MR Vessel Wall Imaging
- ClinicalTrials.gov ID
- NCT05001984
- Acronym / sponsor ID
- TOPICAL-MRI / TOPICAL-MRI
- Keywords
- Intracranial Atherosclerosis, Acute Ischemic Stroke, PCSK9 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 12 Aug 2021 (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.
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke from intracranial atherosclerosis taking lipid lowering therapy.
Detailed description
In this trial, we will conduct a prospective, randomized, open-label, blinded end-point study using high-resolution MRI in patients with acute ischemic stroke from intracranial atherosclerosis to evaluate the efficacy and safety of alirocumab. We hypothesis that additional alirocumab treatment on a background of statin therapy could result in greater stabilization of intracranial plaque and regression of arterial stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, open-label, blinded end-point study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: AlirocumabIn addition to high-intensity statin and antiplatelet treatment, patients will receive treatment of alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks |
| Control group | No intervention | –Patient will have high-intensity statin and antiplatelet treatment. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) score of 1-15
- Ischemic lesions on diffuse-weighted imaging located in the territory of symptomatic intracranial atherosclerosis (ICAS).
- Symptomatic ICAS (above 30%) at the M1 or M2 of the middle cerebral artery, basilar artery or at the intracranial portion of the internal carotid artery or vertebral artery.
- Serum LDL-C ≥70 mg/dL for subjects on lipid-lowering therapies (such as a statin and/or ezetimibe) or LDL-C ≥100 mg/dL for subjects without lipid-lowering therapies.
- Ability to randomize within 7 days of time last known free of new ischemic symptoms.
Key exclusion criteria (18 listed)
- Age <20 years.
- Judged by clinical physician.
- After endovascular intervention or endarterectomy for the symptomatic ICAS.
- Patients with more than 50% stenosis of extra-cranial arteries the relevant arteries on magnetic resonance angiography (MRA), including extra-cranial carotid artery or vertebral arteries.
- Patients with high risk of cardioembolic source, such as atrial fibrillation, acute myocardial infarction, severe heart failure or valvular heart disease.
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: PraluentAlirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks. | Drug | Intervention group |
Primary outcome
The changes of intracranial atherosclerotic plaque: stenosis degree
Time frame: 26 weeks
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as stenosis degree. The degree of stenosis was calculated as: (1-lumen area of stenotic lesion/reference lumen area)×100%.
The changes of intracranial atherosclerotic plaque: percent atheroma volume
Time frame: 26 weeks
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as percent atheroma volume (PAV). The PAV was calculated using the following equation: PAV = Σ(EEM area - Lumen area) / ΣEEM area × 100, where EEM area is the cross-sectional area of the external elastic membrane and Lumen area is the cross-sectional area of the lumen.
The changes of intracranial atherosclerotic plaque: enhancement volume
Time frame: 26 weeks
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as enhancement volume. The enhancement volume was measured as post-contrast plaque enhancement for intracranial arteries and intraplaque hemorrhage.
8 secondary outcomes
Percentage of patients with major cardiovascular events
Time frame: 26 weeks
Percentage of patients with myocardial infarction
Time frame: 26 weeks
Percentage of patients with cardiovascular death
Time frame: 26 weeks
Percentage of patients with stroke
Time frame: 26 weeks
Percentage of patients with ischemic stroke or transient ischemic attack.
Time frame: 26 weeks
Percentage of patients with new ischemic lesions
Time frame: 26 weeks
Percentage of patients with favorable functional recovery
Time frame: 3 months
Changes in serum biomarkers
Time frame: 26 weeks
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 26 Mar 2025.
- Background: PubMed 24135208Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
- Background: PubMed 24481975Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
- Background: PubMed 32333899Hurford R, Wolters FJ, Li L, Lau KK, Kuker W, Rothwell PM; Oxford Vascular Study Phenotyped Cohort. Prevalence, predictors, and prognosis of symptomatic intracranial stenosis in patients with transient ischaemic attack or minor stroke: a population-based cohort study. Lancet Neurol. 2020 May;19(5):413-421. doi: 10.1016/S1474-4422(20)30079-X.
- Background: PubMed 21427797Gao S, Wang YJ, Xu AD, Li YS, Wang DZ. Chinese ischemic stroke subclassification. Front Neurol. 2011 Feb 15;2:6. doi: 10.3389/fneur.2011.00006. eCollection 2011.
- Background: PubMed 31338221Xu W. High-resolution MRI of intracranial large artery diseases: how to use it in clinical practice? Stroke Vasc Neurol. 2019 Jun 20;4(2):102-104. doi: 10.1136/svn-2018-000210. eCollection 2019 Jul.
- Background: PubMed 22367991Xu WH, Li ML, Gao S, Ni J, Yao M, Zhou LX, Peng B, Feng F, Jin ZY, Cui LY. Middle cerebral artery intraplaque hemorrhage: prevalence and clinical relevance. Ann Neurol. 2012 Feb;71(2):195-8. doi: 10.1002/ana.22626.
- Background: PubMed 26671513Petrone L, Nannoni S, Del Bene A, Palumbo V, Inzitari D. Branch Atheromatous Disease: A Clinically Meaningful, Yet Unproven Concept. Cerebrovasc Dis. 2016;41(1-2):87-95. doi: 10.1159/000442577. Epub 2015 Dec 16.
- Background: PubMed 21402390Yamamoto Y, Ohara T, Hamanaka M, Hosomi A, Tamura A, Akiguchi I. Characteristics of intracranial branch atheromatous disease and its association with progressive motor deficits. J Neurol Sci. 2011 May 15;304(1-2):78-82. doi: 10.1016/j.jns.2011.02.006. Epub 2011 Mar 13.
- Background: PubMed 22568537Kim JS, Yoon Y. Single subcortical infarction associated with parental arterial disease: important yet neglected sub-type of atherothrombotic stroke. Int J Stroke. 2013 Apr;8(3):197-203. doi: 10.1111/j.1747-4949.2012.00816.x. Epub 2012 May 9.
- Background: PubMed 31919104Liu D, Liu J, Cai Y, Wong KSL, Liu L. Is the future of symptomatic intracranial atherosclerotic stenosis management promising? J Neurol Neurosurg Psychiatry. 2020 Feb;91(2):122-124. doi: 10.1136/jnnp-2019-321564. No abstract available.
- Background: PubMed 29766750Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
- Background: PubMed 23803136Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
- Individual participant dataSharing planned: No
Related trials for Intracranial Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
RecruitingObservational study
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
Not yet recruiting
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
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. This study is not recruiting at the moment.
Yenchu Huang, MD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alirocumab in people with Intracranial Atherosclerosis and Acute Ischemic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 8 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The changes of intracranial atherosclerotic plaque: stenosis degree (time frame: 26 weeks). The study lists 3 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 NCT05001984, which also lists 24 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 26 Mar 2025.