Nicorandil in Atherosclerosis Risk in Patients With Rheumatoid Arthritis

NCT07800351 | Not Yet Recruiting Phase 3

• 1 other identifier: 36264MS101089/12/25
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Rheumatoid Arthritis (RA; Atherosclerosis

Keywords

Rheumatoid Arthritis (RA); atherosclerosis; nicorandil

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at baseline ( day 1) and 3 months after ( week 13)

Secondary Outcomes (1)

• Incidence of Adverse Events

  Through study completion average of 3-month

Study Arms (2)

Nicorandil Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Participants will receive their ongoing csDMARD therapy alone for 3 months.

Drug: DMARD maintenance

Interventions

DMARD maintenance DRUG

used as control group

Control Group; Nicorandil Group

Nicorandil 10 MG Oral scored Tablet DRUG

Nicorandil 5 mg oral (half of scored tablet 10 mg) taken twice daily before meals added on csDMARD for 3 months.

Nicorandil Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Rheumatology, Rehabilitation and Physical Medicine department -Tanta university hospitals

Tanta, Gharbia Governorate, 31511, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Atherosclerosis

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Salwa El Morsy Abd El Ghanv M Abd El Ghany, MD, PhD

  Rheumatology, Rehabilitation and Physical Medicine department -Tanta university

  STUDY CHAIR

• Mohamed H Abu-Zaid, MD, PhD

  Rheumatology, Rehabilitation and Physical Medicine department -Tanta university

  STUDY DIRECTOR

• Aya M El Shanshory, resident doctor

  Rheumatology, Rehabilitation and Physical Medicine department -Tanta university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hanan H Soliman, professor MD, PhD

CONTACT

0020+01004694431; hanansol@gmail.com

Aya M El Shanshory, resident doctor

CONTACT

01113402504; ayaelshan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)