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临床试验/NCT03195153
NCT03195153Unknown4 期

Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月28日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)

干预措施: Atorvastatin 80mg (Drug)

allopurinol only

Experimental

30 DAYS OF ALLOPURINOL (300 MG)

干预措施: ALLOPURINOL 300 MG (Drug)

statin and allopurinol

Experimental

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Polacco Marina

MD, principal investigator

University of Roma La Sapienza

研究点 (1)

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