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临床试验/NCT05911659
NCT05911659招募中不适用

Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI

Mina Wageh Mohareb1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Platelet Reactivity Index and maximum platelet aggregation

研究概览

简要总结

Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values > 50% were defined as high platelet reactivity.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute coronary syndrome (ACS) undergoing PCI

排除标准

  • Patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.
  • Patients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.

研究组 & 干预措施

Non smokers- non diabetic patients

干预措施: Ticagrelor (Drug)

smokers non diabetic patients

干预措施: Ticagrelor (Drug)

non smokers diabetic patients

干预措施: Ticagrelor (Drug)

smokers diabetic patients

干预措施: Ticagrelor (Drug)

结局指标

主要结局

Platelet Reactivity Index and maximum platelet aggregation

时间窗: 24 hours after PCI

Platelet aggregation indicator

次要结局

未报告次要终点

研究者

发起方
Mina Wageh Mohareb
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mina Wageh Mohareb

Professor

Cairo University

研究点 (1)

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