Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)
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
- 否
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
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 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
Felix Chikita Fredy, MD
cardiology resident
Indonesia University
