NCT07819643Not yet recruitingPhase 4
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Remodeling Evaluation and Stabilization of Carotid Vulnerable Plaques by PCSK9 Inhibitors Using HR-MRI for Early Prediction
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
Carotid artery stenosis is a major cause of ischemic stroke. However, many strokes occur in patients with only mild-to-moderate stenosis. Evidence shows that it is not the degree of narrowing, but the "vulnerability" of the plaque-its internal composition-that determines rupture risk. High-risk (vulnerable) plaques have a large lipid-rich necrotic core, a thin fibrous cap, and intraplaque hemorrhage. Statins can lower cholesterol and stabilize plaques, but some patients still experience progression or recurrent events. PCSK9 inhibitors (such as evolocumab and alirocumab) are a new class of lipid-lowering drugs that reduce LDL cholesterol more strongly than statins alone. They may also have direct effects on the artery wall, improving plaque stability. Whether they can remodel vulnerable carotid plaques and how early this can be detected remains unclear. This study uses high-resolution magnetic resonance imaging (HR-MRI), a non-invasive technique that visualizes plaque internal structure-including the lipid core, fibrous cap, and hemorrhage-to track changes over time. Purpose: The RESCUE study aims to determine whether adding a PCSK9 inhibitor to standard statin therapy can remodel and stabilize vulnerable carotid plaques, and to detect these changes early using HR-MRI. Design: This is a single-center, prospective, randomized, controlled, open-label trial with blinded endpoint evaluation (PROBE design). 120 adults with carotid vulnerable plaques will be enrolled at Beijing Tsinghua Chang Gung Hospital and randomly assigned 1:1 to: (1) Experimental group (n=60): statin PLUS PCSK9 inhibitor (subcutaneous injection); (2) Control group (n=60): statin alone. Follow-up is 24 months. HR-MRI is performed at baseline, 6, 12, and 24 months. Blood samples are collected for lipid and inflammatory markers. HR-MRI analysis is performed by blinded radiologists. Primary Outcome: Change in lipid-rich necrotic core volume by HR-MRI at 12 and 24 months. Secondary Outcomes: Fibrous cap thickness, intraplaque hemorrhage, remodeling index, LDL-C levels, inflammatory markers, and clinical events (stroke, TIA, cardiovascular death) over 24 months. Status: Not yet recruiting. Planned start: January 2027. Conducted at Beijing Tsinghua Chang Gung Hospital, Beijing, China.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Keqiang Zhao
- Diseases
- Stroke
- NCT number
- NCT07819643
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Jan 2027 to the primary completion date, 1 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI contraindications such as metallic implants or claustrophobia.
Other illness
- Allergy or contraindication to PCSK9 inhibitors.
- Active liver disease, myopathy, or creatine kinase (CK) elevation \>5 times the upper limit of normal.
- History of carotid revascularization (carotid endarterectomy \[CEA\] or carotid artery stenting \[CAS\]).
Lab values
- Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 ml/min).
Age
- Life expectancy \<3 years.
Who the study is looking for
- . Carotid stenosis ≥30% detected by carotid ultrasound, not meeting criteria for surgical intervention, and confirmed presence of vulnerable plaque by HR-MRI (meeting any of the following: incomplete or thin fibrous cap \<0.5 mm; lipid-rich necrotic core \[LRNC\] volume ≥40% of plaque volume; intraplaque hemorrhage \[IPH\]; or neovascularization).
- Receiving standard statin therapy (moderate intensity or higher) for ≥3 months, with LDL-C still ≥1.8 mmol/L (70 mg/dL).
- Willing to adhere to follow-up and provide signed informed consent.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.