Managing carotid plaque stability with statins and folic acid

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort study investigates the effect of folic acid on carotid plaque stability in patients receiving statin therapy. Participants are assigned to two groups: statin alone and statin plus folic acid, to explore potential benefits on plaque stability over six months. Eligibility includes adults 18–75 with ultrasound- or CTA-confirmed carotid plaque and no prior carotid interventions. The study uses imaging and blood tests to monitor changes in plaque characteristics and risk markers. Conducted in Shanghai, it aims to inform future randomized trials on folic acid supplementation in this patient population.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Junyi Yan, M.D.
• Email: drsunyudong@hotmail.com
• Phone: +8613480161737

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Photon-counting CT vs conventional CT for carotid plaque in people with carotid artery stenosis

  This study tests whether photon-counting CT gives clearer, more detailed pictures of carotid plaques compared with standard CT in patients with carotid artery stenosis to help characterize plaque features.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07762664

• AI-assisted 4D PET imaging to detect early pancreatic cancer lesions

  This study tests whether AI-assisted 4D long-axial PET imaging with FDG and FAPI can help detect early PDAC lesions in patients with suspected pancreatic tumors.

  Recruiting Ruijin Hospital · Shanghai · NCT07925125

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

  This trial tests whether modular robotic-assisted esophagectomy using the Carina platform works better than conventional 3D thoracoscopic esophagectomy for people with resectable esophageal cancer.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT07888140

• Ivonescimab with pemetrexed and platinum chemotherapy as first-line treatment for advanced malignant pleural mesothelioma

  This study tests whether adding ivonescimab to standard pemetrexed plus platinum-based chemotherapy can help people with newly diagnosed advanced malignant pleural mesothelioma.

  Recruiting at 3 sites Phase 1/2 Ruijin Hospital · Shanghai, Shanghai Municipality and 2 other locations · NCT07885319

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.