Effect of Nicorandil on Atherosclerosis Risk in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Carotid Intima-Media Thickness (CIMT)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nicorandil Group
Participants will receive nicorandil 5 mg twice daily orally before meals in addition to their ongoing csDMARD therapy for 3 months.
干预措施: Nicorandil 10 MG Oral scored Tablet (Drug)
Nicorandil Group
Participants will receive nicorandil 5 mg twice daily orally before meals in addition to their ongoing csDMARD therapy for 3 months.
干预措施: DMARD maintenance (Drug)
Control Group
Participants will receive their ongoing csDMARD therapy alone for 3 months.
干预措施: DMARD maintenance (Drug)
结局指标
主要结局
Change in Carotid Intima-Media Thickness (CIMT)
时间窗: at baseline and after 3 months
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.
Change in Serum Lipoprotein(a) [Lp(a)] Level
时间窗: at baseline and after 3 months
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.
Change in Carotid Intima-Media Thickness (CIMT)
时间窗: at baseline (day 1) and 3 months after (week 13)
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.
Change in Serum Lipoprotein(a) [Lp(a)] Level
时间窗: at baseline ( day 1) and 3 months after ( week 13)
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.
次要结局
- Incidence of Adverse Events(Throughout 3-month study period)
- Incidence of Adverse Events(Through study completion average of 3-month)
研究者
Hanan Hamed Soliman
professor
Tanta University