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临床试验/NCT03960411
NCT03960411Unknown3 期

Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)

Felix Chikita Fredy, MD1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年5月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
80
试验地点
1
主要终点
high sensitivity-CRP

研究概览

简要总结

Subsequent to the loss of myocardium post-myocardial infarction (MI), the affected ventricle undergoes some dynamic structural and functional changes known as remodeling. Cardiac remodeling progresses into heart failure (HF). In this revolutionized percutaneous coronary intervention (PCI) era, the incidence of post-MI HF due to cardiac remodeling remains high. Current standard therapeutic interventions, for HF, aimed solely at correcting a low cardiac output do not necessarily impede HF progression. Recently, doxycycline was found to have an additional biological effect aside from their antimicrobial actions. From several experimental studies and clinical trials, doxycycline showed MMP inhibition activities that can prevent ventricular remodeling. This study aims to evaluate the role of doxycycline in cardiac remodeling prevention post-MI. Our hypothesis is that a better heart function will be observed in STEMI patients who receive a short period of doxycycline administration post-PCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The only party who is not masked is the pharmacist

入排标准

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

入选标准

  • Onset of STEMI <12 hours
  • Anterior wall STEMI or Killip grade II-III or LVEF <50%
  • Undergoing primary PCI

排除标准

  • Signs of infection (clinical judgement plus leukocyte count >15,000)
  • STEMI mechanical complication
  • Moderate-severe valvular disease
  • Allergic to doxycycline
  • Refuse to join the trial

研究组 & 干预措施

Doxycycline

Experimental

Doxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI

干预措施: Doxycycline 100Mg Capsule (Drug)

Placebo

Placebo Comparator

Placebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI

干预措施: Placebo oral capsule (Drug)

结局指标

主要结局

high sensitivity-CRP

时间窗: 24 hours

hs-CRP in mg/L

NT-pro BNP

时间窗: 5 days

NT-pro BNP in pg/ml

ST2

时间窗: 24 hours

ST2 in ng/ml

high sensitivity-Troponin T

时间窗: 12 hours

hs-Troponin T in ng/L

netrophils

时间窗: 24 hours

absolute amount per micro liters

次要结局

  • Mortality rate(4 months)
  • Heart failure incidence(4 months)
  • Re-hospitalization rate(4 months)
  • Left ventricle function and dimension(4 months)

研究者

发起方
Felix Chikita Fredy, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Felix Chikita Fredy, MD

cardiology resident

Indonesia University

研究点 (1)

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