Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug
研究概览
简要总结
Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular disease. It has been implicated as an independent risk factor for cardiovascular disease and premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as well as for patients with essential hypertension. A complete biochemical understanding of the mechanisms by which hyperglycemia causes vascular functional and structural changes associated with the diabetic milieu still eludes us. In recent years, the numerous biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of diabetic vascular disease have been distilled into several unifying hypotheses. The role of chronic hyperglycemia in the development of diabetic microvascular complications and in neuropathy has been clearly established. However, the biochemical or cellular links between elevated blood glucose levels, and the vascular lesions remain incompletely understood. A number of trials have demonstrated that statins therapy as well as angiotensin converting enzyme inhibitors is associated with improvements in endothelial function in diabetes. Although antioxidants provide short-term improvement of endothelial function in humans, all studies of the effectiveness of preventive antioxidant therapy have been disappointing. Actually, control of hyperglycemia thus remains the best way to improve endothelial function and to prevent atherosclerosis and other cardiovascular complications of diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diabetic patient;
- •therapy with aspirin and insulin;
- •patient well responders
排除标准
- •not diabetic patient;
- •patients in dual antiplatelet therapy;
- •patient with severe renal failure;
- •patient poor responders
研究组 & 干预措施
statin only
30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)
干预措施: Atorvastatin 80mg (Drug)
allopurinol only
30 DAYS OF ALLOPURINOL (300 MG)
干预措施: ALLOPURINOL 300 MG (Drug)
statin and allopurinol
30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL
干预措施: Atorvastatin 80mg AND allopurinol 300 mg (Drug)
结局指标
主要结局
Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug
时间窗: fter 30 days of treatment with each drug
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\]
次要结局
未报告次要终点
研究者
Polacco Marina
MD, principal investigator
University of Roma La Sapienza
