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临床试验/NCT02556671
NCT02556671Unknown不适用

Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention

Ruqiong Nie1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Change in Individual Platelet Reactivity Measured by VerifyNow P2Y12 Assay Over Time after Receiving Clopidogrel among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention -- A Cross-Sectional Study

研究概览

简要总结

Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However, inhibition of platelet activation and aggregation after DAPT varies greatly among patients. Some clinical studies have demonstrated that patients with high on-treatment platelet reactivity are at increased risk of major adverse cardiovascular events. Tailored antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting by drug adjustment based on platelet function testing. Unfortunately, the results of 3 major prospective trials (GRAVITAS, ARCTIC, TRIGGER PCI) of personalized antiplatelet therapy are neutral. In these studies, platelet function was only assessed by a single measurement and a single method early after the start of antiplatelet treatment. To test the stability of platelet reactivity measurements over time among patients undergoing PCI, investigators use 3 methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days), with maintenance doses of clopidogrel.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years old.
  • 2.15 ≤ eGFR < 60 ml/min/1.73 m
  • Clinically stable and following PCI between 4 weeks and 1 year.
  • On clopidogrel (75mg/d) and aspirin (100mg/d) treatment at least 4 weeks.

排除标准

  • Conditions that alter platelet function.
  • Conditions that increase bleeding risk.

结局指标

主要结局

Change in Individual Platelet Reactivity Measured by VerifyNow P2Y12 Assay Over Time after Receiving Clopidogrel among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention -- A Cross-Sectional Study

时间窗: up to 6 months

次要结局

未报告次要终点

研究者

发起方
Ruqiong Nie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ruqiong Nie

director of cardiology

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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