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Nicorandil in Atherosclerosis Risk in Patients With Rheumatoid Arthritis

Not Yet RecruitingPhase 3

Sponsor: Tanta University

Conditions: Rheumatoid Arthritis (RA, Atherosclerosis

Interventions: Nicorandil 10 MG Oral scored Tablet, DMARD maintenance

Countries: Egypt

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Tanta, Gharbia Governorate, Egypt