Pharmacodynamic- Pharmacokinetic Trial, Comparative Double Blind, of the Chronic Administration of 150 mg of Slow Release ASA Versus 150 mg of Normal Release ASA, in the Platelet Functionalism.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations
研究概览
简要总结
The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.
详细描述
A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication.
Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the safety of the ASA.
Some previous studies indicate that the slow release form of ASA has a different behaviour in the platelet effect in comparison with plain formulation.
The aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation of ASA.
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
- •Previous episodes of myocardial infarction
- •Previous episodes of instable angina pectoris
- •Previous coronary revascularization
- •Significant arterial coronary disease
排除标准
- •Patients with other pathologies that requires treatment with other antiaggregants
- •Patients in treatment with low molecular weight heparin or oral anticoagulant
- •Patients with antecedents of hypersensibility to ASA
研究组 & 干预措施
ASA
normal release acetylsalicylic acid
干预措施: ASA (Drug)
SR-ASA
slow release acetylsalicylic acid 150 mg
干预措施: slow release acetyl salicylic acid (Drug)
SR-ASA
slow release acetylsalicylic acid 150 mg
干预措施: SR-ASA (Drug)
结局指标
主要结局
To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations
时间窗: 28 days
次要结局
- To evaluate the principal kinetic parameters of both galenic formulations of ASA.(28 days)