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Heart risk in rheumatoid arthritis: could a blood vessel drug help?

NCT ID NCT07800351

Disease control Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether adding nicorandil, a drug that widens blood vessels, to standard rheumatoid arthritis (RA) treatment can reduce the buildup of plaque in arteries. People with RA have a higher risk of atherosclerosis, which can lead to heart attacks and strokes. Researchers will give 46 adults with RA either nicorandil plus their usual medication or their usual medication alone for 3 months. They will measure changes in carotid artery thickness and blood levels of lipoprotein(a), both markers of artery plaque risk, and track any side effects.

What this could mean

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

Active substance
nicorandil, an oral tablet taken twice daily for 3 months alongside standard rheumatoid arthritis medications
What this could lead to
If it works, adding nicorandil to standard rheumatoid arthritis treatment could lower the risk of heart disease and stroke in people with RA.
What could go wrong
This is a small, early-stage trial with only 46 participants, so results may not apply to everyone. Nicorandil can cause side effects, and the 3-month treatment period may be too short to show lasting changes in artery health.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 46 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 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 70 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: 1. Adults aged 18-70 years, diagnosed with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria. 2. Receiving conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy for at least 3 months. 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 1. Chronic autoimmune disease other than rheumatoid arthritis. 2. RA patients receiving biological DMARDs (bDMARDs). 3. Patients on lipid-lowering drugs (e.g., statins, fibrates). 4. Patients with metabolic or endocrine disease (e.g., diabetes mellitus, dyslipidemia). 5. Severe renal or hepatic impairment. 6. Any history of malignancy. 7. Current pregnancy or breastfeeding. 8. Current acute or chronic infection. 9. Currently participating in or has participated in a study of an investigational agent or device within 30 days prior to screening. 10. Known hypersensitivity or allergy to nicorandil or any of its components.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis atherosclerosis prevention target

As listed by the trial registrant

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

Atherosclerosis Rheumatoid arthritis (RA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rheumatology, Rehabilitation and Physical Medicine department -Tanta university hospitals

    Tanta, Gharbia Governorate, 31511, Egypt

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