The Effect of Nicorandil on Rheumatoid Arthritis Patients (NCT07730723) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
The Effect of Nicorandil on Rheumatoid Arthritis Patients
Egypt70 participantsStarted 2026-08
Plain-language summary
The aim of this clinical trial is to determine whether nicorandil works in minimizing disease severity in patients with rheumatoid arthritis. The study will also assess the safety and tolerability of nicorandil. The main questions it aims to answer are:
* Could nicorandil improve disease severity and symptoms of rheumatoid arthritis?
* Does nicorandil lower the number of times participants need to use pain relieve medications?
* Does the nicorandil improve participants functionality and ability to carry out daily activity?
* Does nicorandil correct disease-associated damage and inflammation?
* What side effects do participants have when taking nicorandil? Researchers will compare nicorandil to a placebo (a look-alike substance that contains no drug) to see if nicorandil works to decrease symptoms and severity of rheumatoid arthritis.
Participants will:
* Take nicorandil or a placebo two times daily for 3 months
* Visit the clinic once every month for checkups
* Keep a diary of their symptoms and the number of times they use a pain reliever
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (≥18 years).
* Confirmed diagnosis with RA according to ACR/EULAR 2010 criteria.
* Moderate to severe disease activity (DAS-28 ˃ 3.2).
* Stable on conventional treatment for at least 3 months.
* Adequate kidney and liver function.
Exclusion Criteria:
* Other autoimmune diseases
* Poor patient compliance
* Malignancy or history of malignancy
* Pregnancy or lactation.
* Patients receiving bDMARDs or tsDMARDs.
* Hypersensitivity to nicorandil.
* Left ventricular heart failure or severe hypotension (SBP ˂100 mmHg).
* History of cardiogenic shock.
* History or active gastric ulcer.
* Use of drugs contraindicated with nicorandil (e.g., sildenafil, tadalafil, vardenafil, tricyclic antidepressants, or guanyl cyclase).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of treatment Efficacy
Timeframe: At baseline and at the end of the study (3 months (12 weeks)).