NCT00493779已完成4 期
An Exploratory, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA)
Bristol-Myers Squibb7 个研究点 分布在 4 个国家目标入组 103 人开始时间: 2007年10月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
研究概览
简要总结
The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment
- •Subjects receiving low dose ASA
- •Subjects receiving a statin
- •Current medication regimen (including ASA and statins) must have been stable for three (3) months. i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study
- •Subjects with no clinical history of diabetes mellitis
- •Men and women, ages 18 years or older
排除标准
- 未提供
结局指标
主要结局
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
时间窗: Week 1, Week 2, Week 3, Week 4 (primary timepoint)
Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.
次要结局
- Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin(Week 1, Week 2, Week 3, Week 4)
- Adjusted Mean Percent Changes From Baseline in Hs-CRP(Week 1, Week 2, Week 3, Week 4)
- Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up(Throughout 4-week follow-up period)
研究者
研究点 (7)
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