NCT03385135Unknown不适用
Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease
University Tunis El Manar1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Endothelium-dependent vasodilation
研究概览
简要总结
This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with a 4-weekly check on hematology and biochemistry
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
- Double (Investigator, Outcomes Assessor)
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
- •Diabetes type 2
- •Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month
排除标准
- •Pregnant or breast- feeding women
- •creatinine clearance <60ml/min
- •Known history of gout disease or ongoing treatment with allopurinol
- •Allergy to allopurinol
- •Inability to provide informed consent
研究组 & 干预措施
Allopurinol group
Active Comparator
Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks
干预措施: Allopurinol (Drug)
结局指标
主要结局
Endothelium-dependent vasodilation
时间窗: 2 months
Brachial Artery Flow-Mediated dilation (FMD)
次要结局
- Endothelium-independent vasodilation(2 months)
- Quality of Life (QoL)(2 months)
- Major adverse cardiac events (MACE)(2 months)
研究者
Kasbaoui sami
Principal Investigator
University Tunis El Manar
研究点 (1)
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