A Phase 3 interventional study of Nicorandil 10 MG Oral scored Tablet and DMARD maintenance in Rheumatoid Arthritis (RA and Atherosclerosis, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Tanta University · Phase 3, Interventional, and Treatment
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
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 46 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive nicorandil 5 mg twice daily orally before meals in addition to their ongoing csDMARD therapy for 3 months.
Drug: Nicorandil 10 MG Oral scored Tablet · Drug: DMARD maintenance
Participants will receive their ongoing csDMARD therapy alone for 3 months.
Drug: DMARD maintenance
Nicorandil 5 mg oral (half of scored tablet 10 mg) taken twice daily before meals added on csDMARD for 3 months.
used as control group
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.
Time frame: 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.
Time frame: at baseline ( day 1) and 3 months after ( week 13)
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.
Time frame: Through study completion average of 3-month
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 148 phase 3 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 40. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nicorandil