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临床试验/NCT02101437
NCT02101437已完成不适用

The Relationship of Platelet Micro-RNA Expression and Platelet Reactivity in Patients Under Clopidogrel or Ticagrelor Treatment

Taipei City Hospital1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
miRNA

研究概览

简要总结

For acute coronary syndrome patients undergoing cardiac catheterization after stenting, we will give dual antiplatelet drugs (dual antiplatelet agents) therapy, the choice of the basis of medical criteria (clinical guidelines) routine as aspirin + clopidogrel or aspirin + ticagrelor, according to medical guidelines currently no other disposal alternative proposal (unless adverse drug tolerance or bleeding can not be administered); idea of this experiment for acute coronary syndrome or conventional cardiac catheterization after stenting, platelet miRNA expression (miR-96 , miR-200b, miR-495, miR-107) after cardiac catheterization and interventional treatment of clopidogrel or ticagrelor acceptance of platelet reactivity (PRU) correlation values (given clopidogrel or ticagrelor determined by the clinician, the patient follow-up experiment to track only and observation), aims to explore under different platelet reactivity (hyper-reactive or hypo-reactive), their differences in miRNA performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

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

  • 1 under DAPT (dual antiplatelet therapy) of stable angina patients for elective stent implantation.
  • DAPT 24 hours after treatment PRU (platelet activity units) values. (Drug unresponsive patients was defined as PRU> 235).

排除标准

  • 1.Not suitable for the treatment of patients with DAPT. (Active peptic ulceration or bleeding) 2 patients of aspirin, clopidogrel, ticagrelor, cilostazol medication intolerance.
  • 3 contraindications for aspirin, clopidogrel, ticagrelor, cilostazol drug usage (such as heart failure patients not suitable for use cilostazol).

研究组 & 干预措施

control

Placebo Comparator

normal subjects.

干预措施: miRNA after 1 week (Procedure)

control

Placebo Comparator

normal subjects.

干预措施: miRNA after 1 month (Procedure)

control

Placebo Comparator

normal subjects.

干预措施: miRNA within 24hr (Procedure)

clopidogrel

Active Comparator

subjects received clopidogrel 75mg qd.

干预措施: miRNA within 24hr (Procedure)

clopidogrel

Active Comparator

subjects received clopidogrel 75mg qd.

干预措施: miRNA after 1 week (Procedure)

clopidogrel

Active Comparator

subjects received clopidogrel 75mg qd.

干预措施: miRNA after 1 month (Procedure)

ticagrelor

Active Comparator

subjects received ticagrelor 90mg qd.

干预措施: miRNA within 24hr (Procedure)

ticagrelor

Active Comparator

subjects received ticagrelor 90mg qd.

干预措施: miRNA after 1 week (Procedure)

ticagrelor

Active Comparator

subjects received ticagrelor 90mg qd.

干预措施: miRNA after 1 month (Procedure)

cilostazol

Active Comparator

subjects received cilostazol 100mg bid.

干预措施: miRNA within 24hr (Procedure)

cilostazol

Active Comparator

subjects received cilostazol 100mg bid.

干预措施: miRNA after 1 week (Procedure)

cilostazol

Active Comparator

subjects received cilostazol 100mg bid.

干预措施: miRNA after 1 month (Procedure)

结局指标

主要结局

miRNA

时间窗: 7 days

miRNA-365-3p measure by Roche miRNA kits; PRP(platelet riched plasma) isolated miRNA by isolation Kit, then havest in cDNA synthesis Kit; then perform RT PCR. .

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yueh-Chung, Chen

chief of ICU

Taipei City Hospital

研究点 (1)

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