Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
研究概览
简要总结
The primary aim of our present study is to evaluate the effect of a targeted, intensified, multidimensional intervention compared to conventional treatment of modifiable risk factors for CVD in patients with early RA. The primary endpoint, a composite of death from cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be assessed after 5years' follow-up.
详细描述
The study is a prospective randomised open, blinded endpoint trial with balanced randomisation (1:1) conducted in seven outpatient clinics in Denmark. Follow-up visits for patients in the intervention group are scheduled to occur at baseline and then after 2, 4 and 12 weeks and thereafter every third month for 5 years after randomisation. The control group will be monitored for RA disease activity and comorbidity after 2, 4 weeks, 12 weeks and thereafter following national guidelines for RA. Prevention of CVD risk factors in the control group will be treated in general practice according to national guidelines for diabetes (2011), hypertension (2009) and CVD (2013).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL > 2.5mmol/l.
排除标准
- •Pregnancy
- •Lactation
- •Ongoing/previous DMARD therapy
- •Ongoing/previous steorid therapy
- •Contraindication to any of the trial drugs
- •Current infection with parvovirus B19, hepatitis B, hepatitis C or human immune deficiency virus. Previous report of hospitalisation for myocardial ischaemia defined as follows: a) non-fatal myocardial infarction (MI) defined according to national and international guidelines. b) Acute coronary syndrome (ACS) including acute ischaemic symptoms with possible biomarker changes or elctrocardiographic changes that to not meet the criteria for MI, c) angina pectoris, d) revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
结局指标
主要结局
Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
时间窗: Up to 5 years
Days from randomization to the first of cardiac event. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 31 December 2020. Events will be adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean.
次要结局
- Time to Serious Adverse Event (hospitalizations)(Up to 5 years)
- Time to Death Due to Any Cause(Up to 5 years)
- The proportion of patients having a treatment success(1, 2 and 5 years)
- Time to Non-cardiovascular Death(Up to 5 years)
研究者
MD, PhD, Annemarie Lyng Svensson
MD, PhD
Odense University Hospital