跳至主要内容
临床试验/NCT02628587
NCT02628587Unknown4 期

Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel: Randomized Controlled Trial

Hospital Central San Luis Potosi, Mexico0 个研究点目标入组 60 人开始时间: 2016年2月最近更新:
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
60
主要终点
Platelet reactivity change

研究概览

简要总结

Ischemic heart disease is the leading cause of death and disability in developed countries and is responsible for a third of deaths in persons over 35 years . The most severe form of ischemic heart disease is sudden death and acute coronary syndrome (ACS).

There is evidence that early and optimal treatment of ACS decreases mortality. Within the optimal treatment, these patients must receive a reperfusion therapy as mechanical or pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor; however, it has been shown to have a wide variability in response and this variability could be influenced by different pharmacological, genetic and environmental factors.

Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity in patients with ACS receiving clopidogrel generic versus patent.

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

入选标准

  • 18 and over
  • Diagnosis of acute coronary syndrome
  • Patients receiving 300 mg of Clopidogrel load and a single dose of 75 mg daily
  • Signature of informed consent

排除标准

  • Active bleeding or absolute contraindication for antiplatelet use
  • Chronic kidney disease with creatinine clearance <30 ml / min
  • Liver damage documented as elevated aspartate aminotransferase/alanine aspartate 2 times upper normal limit (UNL) and/or total bilirubin > 2 times UNL
  • Prescribed antiplatelet therapy, other than aspirin

研究组 & 干预措施

Generic clopidogrel

Experimental

Patients are assigned to take generic clopidogrel

干预措施: Generic clopidogrel (Drug)

Patent clopidogrel

Active Comparator

Patients are assigned to take patent clopidogrel (Plavix)

干预措施: Patent clopidogrel (Drug)

结局指标

主要结局

Platelet reactivity change

时间窗: Day 0 and Day 3

Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy

次要结局

未报告次要终点

研究者

发起方
Hospital Central San Luis Potosi, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Manuel López Quijano

Dr. Juan Manuel Lopez Quijano

Hospital Central San Luis Potosi, Mexico

相似试验