Intracranial AtherosclerosisPhase 3EAST-aICASNCT06080256
Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)
A Phase 3 study testing Alirocumab and Atorvastatin in people with Intracranial Atherosclerosis and Atherosclerotic Plaque, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The primary goal of the trial is to investigate whether the lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with asymptomatic intracranial artery stenosis. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Intracranial Atherosclerosis, Atherosclerotic Plaque, Stenosis
- What is being tested?
- Alirocumab and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years and ≤ 75 years.
- There is a 50 to 99% stenosis of a major intracranial artery (internal carotid artery [ICA], vertebral artery [VA], basilar artery [BA] and the M1 segment of middle cerebral artery [MCA]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using high resolution MR.
- There is no TIA or acute ischemic stroke attributed to this ICAS artery; OR, there was an episode of TIA or acute ischemic stroke attributed to this ICAS artery, but this episode occured ≥12 months before randomization.
- To increase the likelihood that the asymptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
- insulin dependent diabetes for at least 15 years. ii. at least 2 of the following atherosclerotic risk factors: hypertension (Blood pressure [BP] ≥ 140/90 or on antihypertensive therapy); dyslipidemia (LDL ≥ 130 mg /dl or high density lipoprotein (HDL) < 40 mg/dl or fasting triglycerides ≥150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event.
- history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.
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- any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic. v. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography.
- any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic.
- Patient agrees with follow-up visits and is available by phone.
- Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Who cannot join
- TIA or acute ischemic stroke attributed to this ICAS artery during the past 12 months before the randomization;
- Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization).
- Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for target vessels/plaques. In case that patients who receive surgeries during follow-up, they will still be followed up for 6 months.
- Intracranial tumor (except meningioma) or any intracranial vascular malformation.
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).
- Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebral spinal fluid pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus.
Show all 16Show fewer
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
- Use of cholesteryl ester transfer protein (CETP) inhibition treatment, mipomersen, or lomitapide within 12 months prior to randomization. Fenofibrate therapy must be stable for at least 6 weeks prior to final screening at a dose that is appropriate for the duration of the study in the judgment of the investigator. Other fibrate therapy (and derivatives) are prohibited.
- Prior use of PCSK9 inhibition treatment before this recruitment.
- Known allergy or contraindication to aspirin, clopidogrel, alirocumab or atorvastatin.
- Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, international normalized ratio (INR) > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (aspartate transaminase [AST] or alanine transaminase [ALT] > 3 x normal, cirrhosis), creatine kinase > 5 times the upper limit of normal (ULN) at final screening, severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20mL/min/1.73 square meter at final screening.
- Major surgery (including open femoral, aortic, cardiac or carotid surgery) within previous 30 days or planned in the 6 months after enrollment.
- Dementia or psychiatric problem that prevents the patient from relevant evaluation or follow-up reliably.
- Co-morbid conditions that may limit survival to less than 6 months.
- Currently breastfeeding, pregnancy, planning to become pregnant and unwilling to use contraception for the duration of this study
- Enrollment in another study that would conflict with the current study.
Trial locations and contacts
1 site in 1 country.
China1 site
the First affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210001
Zhaolu Wang, MD, PhD, 18100613663, wangzhaolu123@163.com
About this study
Official title: Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)----a Pilot Study
The primary goal of the trial is to investigate whether the lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with asymptomatic intracranial artery stenosis.
Read the detailed description
Intracranial atherosclerosis stenosis (ICAS) is one of the most common causes of stroke worldwide and is particularly prevalent in Asian. It accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (Intensive lipid lowering with statin to reach a low-density lipoprotein (LDL)-cholesterol lower than 1.8mmol/L, et al) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group. On the other hand, in view of the ready availability of MRA or CTA , asymptomatic ICAS (ICAS without causing TIA or stroke) can be found at heath checkup. It would be of great significance to take measures to prevent TIA/stroke in those asymptomatic ICAS.
Alirocumab, a member of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. The ODYSSEY OUTCOMES study showed that Alirocumab reduced the risk of cardiovascular events (e.g. cardiovascular death, myocardial infarction and stroke), in patients with atherosclerotic cardiovascular disease.
This pilot study will recruit 80 patients with asymptomatic intracranial artery stenosis, and directly compare Alirocumab on top of statin with statin therapy in changes of intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up.
- Being tested
- Alirocumab, Atorvastatin
- Keywords
- Alirocumab, asymptomatic, intracranial atherosclerotic stenosis
- Medical subject headings
- Intracranial Arteriosclerosis, Plaque, Atherosclerotic, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
alirocumab (75 mg every 2 weeks)
AtorvastatinDrug
Atorvastatin 20-40mg
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab added to statin therapy | Experimental | Alirocumab (75 mg every 2 weeks for 6 months) added to statin (Atorvastatin 20-40mg). Anti-platelet aggregation and risk factor management. Receives: Drug: Alirocumab; Drug: Atorvastatin |
| Statin therapy | Active comparator | Atorvastatin 20-40mg. Anti-platelet aggregation and risk factor management in both arms. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque burden (PB)
lumen area (LA) is manually contoured on T1-weighted SPACE at the most stenotic site (LAplaque). PB is calculated as (1 - LAplaque/OWAplauqe) × 100%
Measured: This will be assessed at 6 months after recruitment.
Degree of stenosis caused by the plaque
degree of stenosis = (1 - Dplaque/Dreference) × 100%, where Dplaque indicated the diameter of the culprit artery at the most stenotic site, and Dreference was the diameter of the normal artery proximal to the plaque
Measured: This will be assessed at 6 months after recruitment.
Plaque enhancement
grading of plaque enhancement: grade 0 indicated enhancement is similar to or less than that of normal-appearing intracranial arterial walls in the same individual; grade 1, enhancement is greater than that of grade 0 but less than that of the pituitary infundibulum; and grade 2, enhancement is similar to or greater than that of the infundibulum. plaque enhancement ratio (ER): circular region of interest (ROI) was drawn within the plaque on pre-contrast and post-contrast T1-weighted SPACE images, respectively. The mean signal intensity (SI) of plaques were obtained. ER = (SIpost - SIpre)/SIpre ×100%
Measured: This will be assessed at 6 months after recruitment.
Remodeling index (RI) of the plaque
the outer wall area (OWA) is manually contoured on T1-weighted SPACE at the most stenotic site (OWAplaque) and the reference site (OWAreference). RI is calculated as OWAplaque/OWAreference × 100%. Arterial remodeling is categorized as positive if RI > 1.05, intermediate if 0.95 ≤ RI ≤ 1.05, and negative if RI < 0.95;
Measured: This will be assessed at 6 months after recruitment.
Presence of T1 hyperintensity in the plaque
the brightest spot of the plaque with SI >150% of that of the reference vessel wall on pre-contrast T1 image
Measured: This will be assessed at 6 months after recruitment.
Plaque distribution: whether it is a concentric plaque or not
a concentric plaque is defined if the wall involvement was more than 75%, and the minimum wall thickness is higher than 50% of the maximum wall thickness.
Measured: This will be assessed at 6 months after recruitment.
Hemodynamic characteristics: Hypoperfusion volume
dynamic susceptibility contrast-perfusion weighted imaging (DSC-PWI) performed and computed using the singular value decomposition deconvolution method using a commercial software NeuBrainCARE (v1.1.10). Hypoperfusion volume on the ipsilateral side of stroke were automatically calculated by use of time to maximum (Tmax) with time thresholds of > 4 seconds and > 6 seconds, respectively.
Measured: This will be assessed at 6 months after recruitment.
Secondary outcomes (2)
Any stroke (ischemic or hemorrhagic) or death during 6 months of follow-up in an intention-to treat analysis.
Measured: This will be assessed during 6 months of follow-up.
Changes in LDL-cholesterol levels
Measured: This will be assessed during 6 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start30 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 The First Affiliated Hospital with Nanjing Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 6 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kezhong Zhang, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080256
- Sponsor's protocol ID
- EAST-aICAS
- Acronym
- EAST-aICAS
- Status last verified
- Dec 2023
- First submitted
- 22 Sep 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
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 24135208Schwartz 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 30403574Raber 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 35368058Chen X, Dai J, Nie P, Gu P, Wang M, Zhang K, Wang Z. Design of the "EAST" strategy in patients with asymptomatic intracranial atherosclerotic stenosis. Clin Neurol Neurosurg. 2024 Oct;245:108507. doi: 10.1016/j.clineuro.2024.108507. Epub 2024 Aug 15.
PubMed 39182330
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)----a Pilot Study
- ClinicalTrials.gov ID
- NCT06080256
- Acronym / sponsor ID
- EAST-aICAS / EAST-aICAS
- Keywords
- Alirocumab, asymptomatic, intracranial atherosclerotic stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 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 primary goal of the trial is to investigate whether the lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with asymptomatic intracranial artery stenosis.
Detailed description
Intracranial atherosclerosis stenosis (ICAS) is one of the most common causes of stroke worldwide and is particularly prevalent in Asian. It accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (Intensive lipid lowering with statin to reach a low-density lipoprotein (LDL)-cholesterol lower than 1.8mmol/L, et al) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group. On the other hand, in view of the ready availability of MRA or CTA , asymptomatic ICAS (ICAS without causing TIA or stroke) can be found at heath checkup. It would be of great significance to take measures to prevent TIA/stroke in those asymptomatic ICAS.
Alirocumab, a member of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. The ODYSSEY OUTCOMES study showed that Alirocumab reduced the risk of cardiovascular events (e.g. cardiovascular death, myocardial infarction and stroke), in patients with atherosclerotic cardiovascular disease.
This pilot study will recruit 80 patients with asymptomatic intracranial artery stenosis, and directly compare Alirocumab on top of statin with statin therapy in changes of intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Alirocumab added to statin therapy | Experimental | Drug: Alirocumab, Drug: AtorvastatinAlirocumab (75 mg every 2 weeks for 6 months) added to statin (Atorvastatin 20-40mg). Anti-platelet aggregation and risk factor management. |
| Statin therapy | Active comparator | Drug: AtorvastatinAtorvastatin 20-40mg. Anti-platelet aggregation and risk factor management in both arms. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 30 years and ≤ 75 years.
- There is a 50 to 99% stenosis of a major intracranial artery (internal carotid artery [ICA], vertebral artery [VA], basilar artery [BA] and the M1 segment of middle cerebral artery [MCA]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using high resolution MR.
- There is no TIA or acute ischemic stroke attributed to this ICAS artery; OR, there was an episode of TIA or acute ischemic stroke attributed to this ICAS artery, but this episode occured ≥12 months before randomization.
- To increase the likelihood that the asymptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
- Patient agrees with follow-up visits and is available by phone.
Key exclusion criteria (16 listed)
- TIA or acute ischemic stroke attributed to this ICAS artery during the past 12 months before the randomization;
- Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization).
- Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for target vessels/plaques. In case that patients who receive surgeries during follow-up, they will still be followed up for 6 months.
- Intracranial tumor (except meningioma) or any intracranial vascular malformation.
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).
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 |
|---|---|---|
| Alirocumabalirocumab (75 mg every 2 weeks) | Drug | Alirocumab added to statin therapy |
| AtorvastatinAtorvastatin 20-40mg | Drug | Alirocumab added to statin therapy, Statin therapy |
Primary outcome
Plaque burden (PB)
Time frame: This will be assessed at 6 months after recruitment.
lumen area (LA) is manually contoured on T1-weighted SPACE at the most stenotic site (LAplaque). PB is calculated as (1 - LAplaque/OWAplauqe) × 100%
Degree of stenosis caused by the plaque
Time frame: This will be assessed at 6 months after recruitment.
degree of stenosis = (1 - Dplaque/Dreference) × 100%, where Dplaque indicated the diameter of the culprit artery at the most stenotic site, and Dreference was the diameter of the normal artery proximal to the plaque
Plaque enhancement
Time frame: This will be assessed at 6 months after recruitment.
grading of plaque enhancement: grade 0 indicated enhancement is similar to or less than that of normal-appearing intracranial arterial walls in the same individual; grade 1, enhancement is greater than that of grade 0 but less than that of the pituitary infundibulum; and grade 2, enhancement is similar to or greater than that of the infundibulum. plaque enhancement ratio (ER): circular region of interest (ROI) was drawn within the plaque on pre-contrast and post-contrast T1-weighted SPACE images, respectively. The mean signal intensity (SI) of plaques were obtained. ER = (SIpost - SIpre)/SIpre ×100%
Remodeling index (RI) of the plaque
Time frame: This will be assessed at 6 months after recruitment.
the outer wall area (OWA) is manually contoured on T1-weighted SPACE at the most stenotic site (OWAplaque) and the reference site (OWAreference). RI is calculated as OWAplaque/OWAreference × 100%. Arterial remodeling is categorized as positive if RI > 1.05, intermediate if 0.95 ≤ RI ≤ 1.05, and negative if RI < 0.95;
Presence of T1 hyperintensity in the plaque
Time frame: This will be assessed at 6 months after recruitment.
the brightest spot of the plaque with SI >150% of that of the reference vessel wall on pre-contrast T1 image
Plaque distribution: whether it is a concentric plaque or not
Time frame: This will be assessed at 6 months after recruitment.
a concentric plaque is defined if the wall involvement was more than 75%, and the minimum wall thickness is higher than 50% of the maximum wall thickness.
Hemodynamic characteristics: Hypoperfusion volume
Time frame: This will be assessed at 6 months after recruitment.
dynamic susceptibility contrast-perfusion weighted imaging (DSC-PWI) performed and computed using the singular value decomposition deconvolution method using a commercial software NeuBrainCARE (v1.1.10). Hypoperfusion volume on the ipsilateral side of stroke were automatically calculated by use of time to maximum (Tmax) with time thresholds of > 4 seconds and > 6 seconds, respectively.
2 secondary outcomes
Any stroke (ischemic or hemorrhagic) or death during 6 months of follow-up in an intention-to treat analysis.
Time frame: This will be assessed during 6 months of follow-up.
Changes in LDL-cholesterol levels
Time frame: This will be assessed during 6 months of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- 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 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 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.
- Derived from this study: PubMed 39182330Chen X, Dai J, Nie P, Gu P, Wang M, Zhang K, Wang Z. Design of the "EAST" strategy in patients with asymptomatic intracranial atherosclerotic stenosis. Clin Neurol Neurosurg. 2024 Oct;245:108507. doi: 10.1016/j.clineuro.2024.108507. Epub 2024 Aug 15.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
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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. This study is not recruiting at the moment.
Kezhong Zhang, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alirocumab and Atorvastatin in people with Intracranial Atherosclerosis and Atherosclerotic Plaque, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 Dec 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaolu Wang, MD (18100613663, wangzhaolu123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque burden (PB) (time frame: This will be assessed at 6 months after recruitment.). The study lists 7 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 NCT06080256, which also lists 4 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 21 Dec 2023.