Prospective Management of Plaque Instability With Statins and Extra Folic Acid

Официальное название

A Prospective, Exploratory, Cohort Clinical Study Comparing the Effects of Oral Statins With or Without Folic Acid on Carotid Plaque Stability.

Обзор

This is a prospective, exploratory, cohort clinical study aiming to further investigate the direct impact of folic acid on the stability of carotid atherosclerotic plaques, building upon substantial clinical evidence confirming that folic acid supplementation reduces the risk of stroke in hypertensive patients, thereby providing a basis for subsequent confirmatory randomized controlled trials. The study will enroll patients with carotid plaques who have not undergone carotid endarterectomy or stent implantation, with lesions defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one site with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or visible plaque formation. Participants will be allocated into Cohort 1 (statin therapy) and Cohort 2 (statin therapy plus folic acid); Cohort 1 will receive oral atorvastatin 20 mg daily, while Cohort 2 will receive an additional oral folic acid 5 mg daily on top of the 20 mg oral atorvastatin regimen, both for a continuous duration of 6 months. Statin therapy in both groups will be standardized and managed in accordance with current clinical guidelines, and all subjects will undergo comprehensive evaluations at baseline and after the 6-month intervention. The primary endpoint is the change in carotid plaque thickness at 6 months post-treatment, while secondary endpoints encompass changes in maximum plaque diameter, analysis of plaque composition ratio, and the regulatory effects on serum metabolic markers and the peripheral immune microenvironment, alongside continuous monitoring of treatment-related adverse events throughout the study to comprehensively evaluate overall safety and tolerability.

Вмешательства

• Препарат Atorvastatin plus folic acid
  Patients will receive oral folic acid 5 mg daily plus 20 mg atorvastatin regimen, with both treatments continuing for a duration of 6 months
• Препарат Atorvastatin
  Patients will receive 20 mg atorvastatin regimen for a duration of 6 months

Первичные конечные точки

• Effects of oral folic acid combined with statins on carotid plaque thickness [Срок оценки: 6 months]

Вторичные конечные точки (4)

• To investigate the effect of oral folic acid combined with statins on the maximum diameter of carotid plaques; [Срок оценки: 6 months]
• To investigate the changes in plaque composition ratios following the administration of oral folic acid combined with statins-including changes in intraplaque calcification area, fibrous cap thickness, intraplaque neovascularization, echo intensity. [Срок оценки: 6 months]
• To evaluate the impact on the proportions of peripheral blood B-cell subsets (via flow cytometry) and serum IgM/IgG titers (via ELISA) [Срок оценки: 6 months]
• Safety and Tolerability: To monitor the incidence of adverse events (AEs) during the treatment period. This includes, but is not limited to, drug-specific safety profiles (e.g., gastrointestinal reactions, hepatic and renal dysfunction, and allergic reac [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Signed and dated written informed consent form (version approved by the Ethics Committee);
• Voluntary participation and commitment to comply with the study protocol;
• Aged 18 to 75 years, regardless of sex;
• Confirmed carotid plaque by ultrasound or computed tomography angiography (CTA), defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one lesion with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or plaque formation;
• Able to cooperate and complete the 6-month study follow-up, including regular imaging examinations and blood sample collections.

Критерии исключения

• History of plaque excision or interventional procedures, such as carotid endarterectomy (CEA) or carotid artery stenting (CAS);
• History of severe hepatic or renal impairment, malignancies, autoimmune diseases, or psychiatric disorders;
• Pregnant or lactating women;
• Hypersensitivity (or allergy) to any components of the study medications;
• Current or long-term regular use of any dietary supplements or medications that may significantly affect the folate metabolic cycle (e.g., vitamin B6, vitamin B12, multivitamins, etc.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital — Шанхай

Публикации

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Идентификаторы

NCT: NCT07680595 · RX-2006-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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