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Completed

NCT Number: NCT00469261

Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Left Ventricular Remodeling Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Remodeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute myocardial infarction
  • Left ventricular ejection fraction less than 40%

Exclusion criteria

  • 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

Treatment and study plan

Doxycycline

Drug

Doxycycline 100 mg bid for seven days after enrollment

Current medical therapy for AMI

Drug

Current medical therapy for AMI

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Official study title

Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study

Acronym: TIPTOP

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 4, 2007
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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