Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study.
Leopoldo Pérez de Isla, Jose L Díaz-Díaz, Manuel J Romero...
https://pubmed.ncbi.nlm.nih.gov/37009731Actively Recruiting
Phase 4
Age: 18Years - 60Years
All Genders
ID06902740
PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis (PISTIAS-2): A Multicenter, Open-label, Blinded-endpoint, Randomized Controlled Trial
Led by Peking Union Medical College Hospital · Updated on 2025-08-07
300
Participants Needed
19
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of a PCSK9 inhibitor combined with statin therapy compared to statin alone to treat asymptomatic intracranial atherosclerosis (ICAS). ICAS, a major cause of ischemic stroke, involves narrowing of brain arteries without symptoms but increases risk for stroke and cognitive decline. This multicenter, open-label, randomized trial aims to provide evidence for preventing ICAS-related brain and vascular problems. Participants aged 18 to 60 with 50% to 99% narrowing in major brain arteries will be randomly assigned to two groups. One group will receive Recaticimab, a PCSK9 inhibitor given every 12 weeks, plus daily statin (rosuvastatin or atorvastatin). The other group will get daily statin alone. Ezetimibe may be added based on cholesterol levels. Treatment lasts 24 weeks with an option for longer follow-up. During the study, researchers will use high-resolution MRI to measure changes in artery plaque size from baseline to week 24. They will also monitor artery narrowing, stroke or transient ischemic attacks, blood markers related to brain injury, cardiovascular events, silent brain infarcts, and cholesterol levels. After treatment, participants will be followed for over a year by clinical or phone visits to assess long-term effects and safety.
CONDITIONS
Brief Title
PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, male or female
- Asymptomatic intracranial artery stenosis (50%-99%) in specific brain artery segments confirmed by angiography
- Atherosclerosis confirmed as cause of artery narrowing by high-resolution MRI
- No previous ischemic stroke or transient ischemic attack
- Baseline low-density lipoprotein cholesterol (LDL-C) of 2.6 mmol/L or higher
- Signed informed consent
You will not qualify if you...
- Non-atherosclerotic intracranial artery stenosis or other vascular diseases like arterial dissection, moya moya disease, vasculitis, or infections
- Significant extracranial vessel narrowing adjacent to target artery (50% or more)
- Previous or planned endovascular treatment of target artery within 6 months
- Any intracranial bleeding within 90 days prior to enrollment
- Presence of brain tumors, cerebral aneurysms, or arteriovenous malformations needing intervention
- Major surgery within 30 days before or planned within 6 months after enrollment
- Certain heart conditions like mitral stenosis, mechanical valve, endocarditis, recent heart attack, or atrial fibrillation
- Severe heart failure (NYHA class III or IV) or low heart pumping function (ejection fraction under 30%)
- Severe liver or kidney dysfunction based on lab tests
- Active bleeding or blood clotting disorders
- Systemic autoimmune diseases such as lupus or Behçet's disease
- Dementia or psychiatric problems limiting outpatient adherence
- Contraindications to MRI such as metallic implants, claustrophobia, or allergies
- Uncontrolled high blood pressure during screening
- Prior use of PCSK9 inhibitors
- Known intolerance or allergy to statins
- Pregnancy, breastfeeding, or planning pregnancy
- Currently participating in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants receive either Recaticimab combined with statin therapy or statin therapy alone to evaluate the effect on intracranial atherosclerosis.
Visits every 12 weeks for Recaticimab dosing plus additional visits for statin management and assessments during treatment
Follow-up
Duration - More than 1 year
Participants are followed clinically or by telephone for over one year to monitor long-term effects after treatment ends.
Periodic clinical or telephone follow-up visits
Trial Site Locations
Total: 19 locations
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Not Yet Recruiting
3
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
Meizhou, Guangdong, China
Not Yet Recruiting
4
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China
Not Yet Recruiting
5
Peking University Third Hospital Qinhuangdao Hospital
Qinhuangdao, Hebei, China
Not Yet Recruiting
6
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China, 050051
Actively Recruiting
7
Tangshan Worker's Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
8
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Not Yet Recruiting
9
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, China
Not Yet Recruiting
10
Taihe Hospital
Shiyan, Hubei, China, 442000
Not Yet Recruiting
11
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
12
Baotou Central Hospital
Baotou, Inner Mongolia, China, 014000
Not Yet Recruiting
13
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
14
Jining First People's Hospital
Jining, Shandong, China, 272000
Not Yet Recruiting
15
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Not Yet Recruiting
16
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
17
Weifang People's Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
18
Chongqing General Hospital
Chongqing, China
Not Yet Recruiting
19
Huashan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
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Research Team
W
Weihai Xu, MD
Y
Yiyang Liu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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