Rheumatoid Arthritis (RAPhase 3NCT07800351
Nicorandil in Atherosclerosis Risk in Patients With Rheumatoid Arthritis
A Phase 3 study testing Nicorandil 10 MG Oral scored Tablet and DMARD maintenance in people with Rheumatoid Arthritis (RA and Atherosclerosis, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn about the effects of adding nicorandil to conventional Disease-Modifying Antirheumatic Drugs(DMARDs) in treatment of patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis (RA, Atherosclerosis
- What is being tested?
- Nicorandil 10 MG Oral scored Tablet and DMARD maintenance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years, diagnosed with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.
- Receiving conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy for at least 3 months.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Chronic autoimmune disease other than rheumatoid arthritis.
- RA patients receiving biological DMARDs (bDMARDs).
- Patients on lipid-lowering drugs (e.g., statins, fibrates).
- Patients with metabolic or endocrine disease (e.g., diabetes mellitus, dyslipidemia).
- Severe renal or hepatic impairment.
- Any history of malignancy.
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- Current pregnancy or breastfeeding.
- Current acute or chronic infection.
- Currently participating in or has participated in a study of an investigational agent or device within 30 days prior to screening.
- Known hypersensitivity or allergy to nicorandil or any of its components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Rheumatology, Rehabilitation and Physical Medicine department -Tanta university hospitals
Tanta, Gharbia Governorate, 31511
hanan H Soliman, professor MD PhD, 01004694431 ext. 0020, hanansol@gmail.com
Aya M El Shanshory, residant, 01113402504 ext. 0020, ayaelshan@gmail.com
About this study
Official title: Effect of Nicorandil on Atherosclerosis Risk in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial.
The goal of this clinical trial is to learn about the effects of adding nicorandil to conventional Disease-Modifying Antirheumatic Drugs(DMARDs) in treatment of patients with rheumatoid arthritis. The main questions it aims to answer are:
Does adding nicorandil to conventional DMARDs in treatment of patients with rheumatoid arthritis reduce the risk of plaque buildup in arteries (atherosclerosis) ? and What medical problems may participants have when taking nicorandil ?
Read more
Participants will:
Take nicorandil added to DMARDs or DMARDs only for 3 months patient will be assessed at baseline and 3 months after for disease activity and risk of plaque formation over vascular wall
Keep a diary of their symptoms and possible side effects
Read the detailed description
RA is associated with significant risk of cardiovascular (CV) disease. Atherosclerosis is notably accelerated in RA patients, driven by a combination of chronic systemic inflammation, endothelial dysfunction, and traditional CV risk factors including hypertension, dyslipidemia, and insulin resistance.
the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), effectively control joint inflammation and disease activity, but doesnot affect the risk of atherosclerosis.
Nicorandil is a hybrid drug that combines nitrate-like vasodilatory properties with the activation of ATP-sensitive potassium (K_ATP) channels. It has been extensively studied in cardiovascular medicine for its vasodilatory, anti-ischemic, and endothelial-stabilizing effects. Recent preclinical and clinical evidence suggests that nicorandil also possesses anti-inflammatory properties, making it a promising candidate for vascular protection in inflammatory conditions such as RA.
Carotid intima-media thickness (CIMT) is a validated, non-invasive imaging biomarker for subclinical atherosclerosis. It reflects structural arterial changes and is predictive of future cardiovascular events. In RA, CIMT is frequently elevated even in the absence of overt CV disease, correlating with disease duration, activity, and systemic inflammation. Changes in CIMT serve as a surrogate endpoint for evaluating the progression or regression of atherosclerosis in interventional trials.
Lipoprotein(a) [Lp(a)] has emerged as a promising biomarker for predicting atherosclerotic risk. Elevated Lp(a) levels contribute to accelerated atherogenesis by promoting endothelial dysfunction, oxidative stress, and recruitment of pro-inflammatory immune cells within the vascular wall. Patients with RA often exhibit elevated Lp(a) levels compared to healthy individuals, which has been associated with a higher risk of atherosclerosis. Among autoimmune disorders, RA exhibits the strongest association with elevated Lp(a) in the context of atherosclerosis.
both will be used to assess risk reduction.
- Conditions
- Rheumatoid Arthritis (RA, Atherosclerosis
- Being tested
- Nicorandil 10 MG Oral scored Tablet, DMARD maintenance
- Keywords
- Rheumatoid Arthritis (RA), atherosclerosis, nicorandil
- Medical subject headings
- Arthritis, Rheumatoid, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 10 MG Oral scored TabletDrug
Nicorandil 5 mg oral (half of scored tablet 10 mg) taken twice daily before meals added on csDMARD for 3 months.
DMARD maintenanceDrug
used as control group
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil Group | Experimental | Participants will receive nicorandil 5 mg twice daily orally before meals in addition to their ongoing csDMARD therapy for 3 months. Receives: Drug: Nicorandil 10 MG Oral scored Tablet; Drug: DMARD maintenance |
| Control Group | Active comparator | Participants will receive their ongoing csDMARD therapy alone for 3 months. Receives: Drug: DMARD maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Carotid Intima-Media Thickness (CIMT)
Change from baseline in carotid intima-media thickness in mm measured by ultrasonography. CIMT is a validated, non-invasive imaging biomarker for subclinical atherosclerosis and reflects structural arterial changes.
Measured: at baseline (day 1) and 3 months after (week 13)
Change in Serum Lipoprotein(a) [Lp(a)] Level
Change from baseline in serum Lp(a) levels measured using ELISA (Enzyme-Linked Immunosorbent Assay). Elevated Lp(a) levels contribute to accelerated atherogenesis and are associated with higher atherosclerosis risk in RA patients.
Measured: at baseline ( day 1) and 3 months after ( week 13)
Secondary outcomes (1)
Incidence of Adverse Events
Monitoring of adverse events, including side effects and adverse events that may be related to tested drug and reported during the study.
Measured: Through study completion average of 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Hamed Soliman, Tanta University
- Investigators
- Salwa El Morsy Abd El Ghanv M Abd El Ghany, MD, PhD, Study chair, Rheumatology, Rehabilitation and Physical Medicine department -Tanta universityMohamed H Abu-Zaid, MD, PhD, Study director, Rheumatology, Rehabilitation and Physical Medicine department -Tanta universityAya M El Shanshory, resident doctor, Principal investigator, Rheumatology, Rehabilitation and Physical Medicine department -Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800351
- Sponsor's protocol ID
- 36264MS101089/12/25
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicorandil on Atherosclerosis Risk in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07800351
- Acronym / sponsor ID
- 36264MS101089/12/25
- Conditions
- Rheumatoid Arthritis (RA, Atherosclerosis
- Keywords
- Rheumatoid Arthritis (RA), atherosclerosis, nicorandil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the effects of adding nicorandil to conventional Disease-Modifying Antirheumatic Drugs(DMARDs) in treatment of patients with rheumatoid arthritis. The main questions it aims to answer are:
Does adding nicorandil to conventional DMARDs in treatment of patients with rheumatoid arthritis reduce the risk of plaque buildup in arteries (atherosclerosis) ? and What medical problems may participants have when taking nicorandil ?
Participants will:
Take nicorandil added to DMARDs or DMARDs only for 3 months patient will be assessed at baseline and 3 months after for disease activity and risk of plaque formation over vascular wall
Keep a diary of their symptoms and possible side effects
Detailed description
RA is associated with significant risk of cardiovascular (CV) disease. Atherosclerosis is notably accelerated in RA patients, driven by a combination of chronic systemic inflammation, endothelial dysfunction, and traditional CV risk factors including hypertension, dyslipidemia, and insulin resistance.
the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), effectively control joint inflammation and disease activity, but doesnot affect the risk of atherosclerosis.
Nicorandil is a hybrid drug that combines nitrate-like vasodilatory properties with the activation of ATP-sensitive potassium (K_ATP) channels. It has been extensively studied in cardiovascular medicine for its vasodilatory, anti-ischemic, and endothelial-stabilizing effects. Recent preclinical and clinical evidence suggests that nicorandil also possesses anti-inflammatory properties, making it a promising candidate for vascular protection in inflammatory conditions such as RA.
Carotid intima-media thickness (CIMT) is a validated, non-invasive imaging biomarker for subclinical atherosclerosis. It reflects structural arterial changes and is predictive of future cardiovascular events. In RA, CIMT is frequently elevated even in the absence of overt CV disease, correlating with disease duration, activity, and systemic inflammation. Changes in CIMT serve as a surrogate endpoint for evaluating the progression or regression of atherosclerosis in interventional trials.
Lipoprotein(a) [Lp(a)] has emerged as a promising biomarker for predicting atherosclerotic risk. Elevated Lp(a) levels contribute to accelerated atherogenesis by promoting endothelial dysfunction, oxidative stress, and recruitment of pro-inflammatory immune cells within the vascular wall. Patients with RA often exhibit elevated Lp(a) levels compared to healthy individuals, which has been associated with a higher risk of atherosclerosis. Among autoimmune disorders, RA exhibits the strongest association with elevated Lp(a) in the context of atherosclerosis.
both will be used to assess risk reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicorandil Group | Experimental | Drug: Nicorandil 10 MG Oral scored Tablet, Drug: DMARD maintenanceParticipants will receive nicorandil 5 mg twice daily orally before meals in addition to their ongoing csDMARD therapy for 3 months. |
| Control Group | Active comparator | Drug: DMARD maintenanceParticipants will receive their ongoing csDMARD therapy alone for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-70 years, diagnosed with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.
- Receiving conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy for at least 3 months.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (10 listed)
- Chronic autoimmune disease other than rheumatoid arthritis.
- RA patients receiving biological DMARDs (bDMARDs).
- Patients on lipid-lowering drugs (e.g., statins, fibrates).
- Patients with metabolic or endocrine disease (e.g., diabetes mellitus, dyslipidemia).
- Severe renal or hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicorandil 10 MG Oral scored TabletNicorandil 5 mg oral (half of scored tablet 10 mg) taken twice daily before meals added on csDMARD for 3 months. | Drug | Nicorandil Group |
| DMARD maintenanceused as control group | Drug | Control Group, Nicorandil Group |
Primary outcome
Change in Carotid Intima-Media Thickness (CIMT)
Time frame: at baseline (day 1) and 3 months after (week 13)
Change from baseline in carotid intima-media thickness in mm measured by ultrasonography. CIMT is a validated, non-invasive imaging biomarker for subclinical atherosclerosis and reflects structural arterial changes.
Change in Serum Lipoprotein(a) [Lp(a)] Level
Time frame: at baseline ( day 1) and 3 months after ( week 13)
Change from baseline in serum Lp(a) levels measured using ELISA (Enzyme-Linked Immunosorbent Assay). Elevated Lp(a) levels contribute to accelerated atherogenesis and are associated with higher atherosclerosis risk in RA patients.
1 secondary outcome
Incidence of Adverse Events
Time frame: Through study completion average of 3-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salwa El Morsy Abd El Ghanv M Abd El Ghany, MD, PhD study chair
Rheumatology, Rehabilitation and Physical Medicine department -Tanta university
Mohamed H Abu-Zaid, MD, PhD study director
Rheumatology, Rehabilitation and Physical Medicine department -Tanta university
Aya M El Shanshory, resident doctor principal investigator
Rheumatology, Rehabilitation and Physical Medicine department -Tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicorandil 10 MG Oral scored Tablet and DMARD maintenance in people with Rheumatoid Arthritis (RA and Atherosclerosis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hanan H Soliman, professor MD, PhD (0020+01004694431 ext. 0020, hanansol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Carotid Intima-Media Thickness (CIMT) (time frame: at baseline (day 1) and 3 months after (week 13)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.