NCT00371501已完成4 期
Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- endothelial activation markers
研究概览
简要总结
The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).
详细描述
To study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus. Subclinical atherosclerosis is assessed by ultrasound study of the carotid vessels and CT scan of the coronary arteries for calcium scores. Blood markers of endothelial activation will also be studied.
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
- Double (Participant, Investigator)
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
- •Age > 18 years
- •Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
- •Presence of any two of the following risk factors:
- •SLE duration of >= 5 years
- •Postmenopausal
- •Age >= 40 years
- •Diabetes mellitus
- •Hypertension (140/90 mmHg)
- •Serum low density lipoprotein (LDL) level >= 2.6 mmol/L or total cholesterol >= 5.5 mmol/L
- •Obesity (body mass index >= 27 kg/m2)
- •Chronic current smoker
- •Positive antiphospholipid antibodies
- •Renal function impairment
- •Persistent proteinuria >= 1 gm/day for >= 6 months
- •Informed consent obtained
排除标准
- •Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
- •Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
- •Patients with history of arterial or venous thromboembolism
- •Patients receiving aspirin or other anti-platelet agents
- •Patients receiving long-term non-aspirin NSAIDs
- •Patients receiving anticoagulation therapy (e.g., warfarin)
- •Patients with history of intolerance or allergy to the statins
- •Pregnant or lactating women
研究组 & 干预措施
treatment arm 1
Active Comparator
干预措施: Rosuvastatin (Drug)
Treatment arm 2
Placebo Comparator
干预措施: placebo (Drug)
treatment arm 3
Active Comparator
aspirin
干预措施: aspirin (Drug)
treatment arm 4
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
endothelial activation markers
时间窗: 12 months
次要结局
- carotid intima media thickness(24 months)
- coronary Agatston score(60 months)
- Thrombotic events(60 months)
- adverse events(60 months)
研究者
研究点 (1)
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