Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- platelets aggregation assessed by two tests (PFA100 and VerifyNow)
研究概览
简要总结
The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •diabete mellitus type 2
- •asa since 30 days at least
- •plts >150000 and <450000
排除标准
- •recent ACS (within 30 days)
- •anticoagulant therapy
- •haemorragic diathesis
研究组 & 干预措施
asa resistant
asa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate.
干预措施: lysine acetylsalicylate (Drug)
结局指标
主要结局
platelets aggregation assessed by two tests (PFA100 and VerifyNow)
时间窗: 24 hours
diabetic patients found aspirin resistant receive and infusion of 288 mg of lysine acetylsalicylate and they are tested again 24 h after the infusion to investigate if aspirin resistance have been reversed.
次要结局
- stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate(1 month)
研究者
Marta Bisi
MD
Azienda Ospedaliera San Giovanni Battista