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Could a simple vitamin boost plaque stability and cut stroke risk?

NCT ID NCT07680595

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study investigates whether adding folic acid to standard statin therapy can make carotid artery plaques more stable, potentially reducing stroke risk. Researchers will enroll 180 adults aged 18 to 75 with carotid plaque buildup, giving half of them atorvastatin alone and the other half atorvastatin plus folic acid for six months. The main goal is to see if the combination reduces plaque thickness more than statins alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atorvastatin and folic acid
What this could lead to
If adding folic acid to statins improves plaque stability, it could lead to a simple, low-cost way to lower stroke risk in people with carotid artery disease.
What could go wrong
This is an early exploratory study with only 180 participants, so results may not apply broadly. The 6-month treatment period is short, and the benefits of folic acid on plaque stability are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carotid atherosclerotic plaque

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

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