NCT00818337已完成4 期
Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Women Aspirin Resistant
研究概览
简要总结
The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at least 19 years old
- •Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
- •Able and willing to provide informed consent
排除标准
- •Pregnancy or breastfeeding
- •Known CHD
- •Currently taking clopidogrel or ticlopidine
- •Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
- •Allergy or hypersensitivity to salicylates
- •Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
- •Currently participating in another investigational drug or device study
研究组 & 干预措施
Aspirin 81mg
Active Comparator
Resistant
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of Women Aspirin Resistant
时间窗: Baseline
Aspirin responsive unit (ARU) \> 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.
次要结局
- Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg(2 weeks)
研究者
研究点 (1)
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