Nicorandil in Atherosclerosis Risk in Patients With Rheumatoid Arthritis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTanta University
About this 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 ?
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nicorandil 10 MG Oral scored Tablet
DrugNicorandil 5 mg oral (half of scored tablet 10 mg) taken twice daily before meals added on csDMARD for 3 months.
DMARD maintenance
Drugused as control group
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Nicorandil GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)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.
Time frame
Through study completion average of 3-monthSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: