Prospective Management of Plaque Instability With Statins and Extra Folic Acid (PROMISE)
1 juillet 2026 mis à jour par: Ruijin Hospital
A Prospective, Exploratory, Cohort Clinical Study Comparing the Effects of Oral Statins With or Without Folic Acid on Carotid Plaque Stability.
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
180
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Junyi Yan, M.D.
- Numéro de téléphone: +8613480161737
- E-mail: drsunyudong@hotmail.com
Lieux d'étude
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200433
- Recrutement
- Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
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Contact:
- Yudong Sun
- Numéro de téléphone: 18818263589
- E-mail: drsunyudong@hotmail.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Statine
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Patients will receive 20 mg atorvastatin regimen for a duration of 6 months
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Expérimental: Statin + Folic acid
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Patients will receive oral folic acid 5 mg daily plus 20 mg atorvastatin regimen, with both treatments continuing for a duration of 6 months
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effects of oral folic acid combined with statins on carotid plaque thickness
Délai: 6 months
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Change from baseline in carotid plaque thickness at 6 months post-treatment
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6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To investigate the effect of oral folic acid combined with statins on the maximum diameter of carotid plaques;
Délai: 6 months
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Changes in maximum plaque diameter
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6 months
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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.
Délai: 6 months
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Plaque composition ratio: To observe post-treatment changes in intraplaque calcification area and fibrous cap thickness; to quantify intraplaque neovascularization density via contrast-enhanced ultrasound (CEUS); and to analyze changes in plaque echogenicity (grayscale values) in order to evaluate the stability of plaque components
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6 months
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To evaluate the impact on the proportions of peripheral blood B-cell subsets (via flow cytometry) and serum IgM/IgG titers (via ELISA)
Délai: 6 months
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Determination of peripheral blood B-cell subset proportions (via flow cytometry) and serum IgM/IgG titers (via ELISA)
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6 months
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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
Délai: 6 months
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Safety and tolerability: To record the incidence rate of adverse events (AEs) during the treatment period
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2026
Achèvement primaire (Estimé)
1 septembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
22 juin 2026
Première soumission répondant aux critères de contrôle qualité
1 juillet 2026
Première publication (Réel)
2 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juillet 2026
Dernière vérification
1 mars 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RX-2006-001
Plan pour les données individuelles des participants (IPD)
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