NCT01011257撤回4 期
Methods to Augment the Efficacy of Aspirin and Clopidogrel in Healthy Subjects (ASA Only) and Patients With Stable Coronary Artery Disease (Taking Clopidogrel Only) or (Taking Clopidogrel & ASA) With an Elevated Platelet Turnover (Reticulated Platelets).
Neil Kleiman, MD1 个研究点 分布在 1 个国家开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover.
研究概览
简要总结
The investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will augment their antiplatelet efficacy in patients with an elevated platelet turnover (as measured by the proportion of reticulated (young) platelets) compared with once daily dosing.
详细描述
- To study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg.
- To study whether in patients with stable coronary artery disease (CAD) with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg.
- To study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg and clopidogrel 75 mg will be more effective in inhibiting platelets compared with once daily of both aspirin and clopidogrel.
- To study whether in patients with stable coronary artery disease (CAD), increased platelet turnover and aspirin resistance, an oral fatty acid (docosahexaenoic acid (DHA) and eicosapentanoic acid (EPA), 4 gm/day) supplementation will increase the efficacy of aspirin by modifying platelet function compared to once a day aspirin 81 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A: Healthy subjects aged 18-64 years with no evidence of coronary artery disease or any major risk factors for CAD including smoking, diabetes mellitus, hyperlipidemia, hypertension and obesity.
- •Group B: Patients with known CAD aged 18-64 years taking aspirin 81 mg daily as the only antiplatelet therapy. Patients should be in stable condition and at least one month post myocardial infarction.
- •Group C: Patients with known stable CAD aged 18-64 years taking aspirin 81 mg and clopidogrel 75 mg daily. Patients should be in stable condition and at least one month post myocardial infarction.
排除标准
- •Subjects will be excluded if they used NSAID's within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy.
- •Other exclusion criteria include contraindications to aspirin including active bleeding, hypersensitivity, thrombocytopenia (platelet count < 50,000) and anemia (hemoglobin < 10.0 gm/dl).
- •We will also exclude patients with unstable angina and recent (less than a month) CABG or PCTA.
研究组 & 干预措施
Aspirin 81 mg, 1 tab twice daily
Active Comparator
All participants to take one aspirin (81mg per tab) twice daily.
干预措施: Asprin (Drug)
Clopidogrel 75 mg 1 tab daily
Active Comparator
Only stable CAD participants will take Clopidogrel (75mg per tab) daily.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Neil Kleiman, MD
Principal Investigator
The Methodist Hospital Research Institute
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionSAcute Coronary DiseaseAngina UnstableNCT00335452Sanofi25,086
已完成
3 期
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial InfarctionAcute Coronary SyndromesNCT00714961Sanofi3,491
招募中
3 期
Combining Aspirin With Cilostazol or Clopidogrel in Minor Stroke or TIAIschemic StrokeNCT06591299Kafrelsheikh University870
招募中
3 期
Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIAIschemic StrokeNCT06591351Kafrelsheikh University870
已完成
1 期
Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)Healthy VolunteersNCT01108588Merck Sharp & Dohme LLC15