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Safety and efficacy of alirocumab in improving early neurologic deterioration in patients with branch atheromatous disease :a multicenter, randomized, parallel controlled clinical trial

Safety and efficacy of alirocumab in improving early neurologic deterioration in patients with branch atheromatous disease :a multicenter, randomized, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097071
Enrollment
Unknown
Registered
2025-02-12
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Branch atheromatous disease (BAD)

Interventions

Control group:Standard treatment
Alirocumab group:Treatment with alixirumab

Sponsors

Ganzhou people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years; 2. Patients who meet diagnostic criteria for BAD: (1) First meet the diagnostic criteria for acute ischemic stroke; (2) Ischemic stroke in the lenticular artery region: DWI showed that the infarct lesions in the corresponding blood supply area involved 3 or more levels in the horizontal position; The lenticular artery supply areas are: most of the putamen nucleus, the lateral part of the globus pallidus, the head and body of the caudate nucleus, the forelimbs of the internal capsule, the upper part of the internal capsule, and the radial crown around the ventricles; (3) Ischemic stroke in the parapontine median artery region: DWI showed that the infarct was connected to the brain surface on the ventral side of the pont, and the lesion was close to the midline, located on one side and not exceeding the midline; 3. NIHSS score of 3-8 points; 4. mRS<=1 point before onset; 5. Patients and their families voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Comorrhage or other pathological brain disorders such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis) based on baseline head CT or MRI examinations; 2. CTA or DSA examination shows the stenosis of the responsible large vessel >=70%; 3. DWI showed cortical infarction, watershed infarction and multiple cerebral infarctions; 4. Cerebral infarction caused by other causes, such as cardiogenic cerebral embolism, immune or infectious vasculitis, abnormal coagulation function and other reasons (such as vasculitis, shock, antiphospholipid antibody syndrome, etc.); 5. History of cirrhosis, chronic active hepatitis, or severe liver disease; 6. Hepatic insufficiency or renal insufficiency (hepatic insufficiency is defined as ALT value > 2 times the upper limit of normal or AST value > 2 times the upper limit of normal; Renal insufficiency is defined as serum creatinine > 1.5 times the upper limit of normal or glomerular filtration eGFR <50ml/min); 7. Have severe non-cardiovascular and cerebrovascular disease with an expected survival time of less than 90 days; 8. Inability to understand or obey the study due to mental disorders, cognitive or emotional disorders, etc., which the investigator considers inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
The incidence rate of END within 7 days;

Secondary

MeasureTime frame
The incidence of ischemic stroke at day 30 and 90;The incidence of TIA at day 30 and 90;The incidence of unfavorable functional outcomes (mRS score >1) at day 30 and 90;The LDL-C levels on day 7 and 30;Adverse events within 30 days;Serious adverse events within 30 days;An increase in creatine kinase or abnormal liver function within 30 days;The rate of improvement within 7 days or 14 days;

Countries

China

Contacts

Public ContactXianghong Liu

Ganzhou people's hospital

liuxianghong2018@sina.com+86 797 5889981

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026