Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 主要终点
- Reduction of LV dilation (six months versus baseline LV end-diastolic volume index by 2D-echocardiogram [echo]) more than 50% in the treated group in comparison to the placebo group
研究概览
简要总结
The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in preventing left ventricular (LV) remodeling.
详细描述
A myocardial interstitial matrix, that provides structural support and integrity to the myocardium, is a key element to determine post infarction left ventricular remodeling (LVR).
The metalloproteinases (MMPs), an enzymatic system secreted in the extracellular medium by macrophages, has been shown to be able to degrade the most important extracellular matrix components.
Various animal experimental models have demonstrated that MMP specific inhibition in the first phase of myocardial infarction is able to contrast LVR. Doxycycline, a member of the tetracyclines, has been shown to block various inflammation mediators and to attenuate MMP-2 and MMP-9 expression and activity at a sub-antimicrobial dosage. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction.
In the present study we want to evaluate if a treatment with doxycycline (100 mg b.i.d.) in the first seven days after a reperfused large (ejection fraction less than 40%) acute myocardial infarction, is effective in preventing six-month LVR.
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
- None
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
- •Acute myocardial infarction
- •Left ventricular ejection fraction less than 40%
排除标准
- •No written consensus
- •Allergy to tetracycline
- •Mechanical complication of AMI
- •Previous myocardial infarction
- •Valvular and/or myocardiopathy known or suspected
- •Renal failure (creatinine above 2 mg/dL)
- •Connective tissue disease
- •Pregnancy
研究组 & 干预措施
Doxycycline
Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy
干预措施: Doxycycline (Drug)
Standard Therapy
Pts with AMI treated with Primary PCI and current medical therapy
干预措施: Current medical therapy for AMI (Drug)
结局指标
主要结局
Reduction of LV dilation (six months versus baseline LV end-diastolic volume index by 2D-echocardiogram [echo]) more than 50% in the treated group in comparison to the placebo group
时间窗: 6 months
次要结局
- Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling(6 months)
研究者
David Antoniucci
MD
Careggi Hospital