Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction Left Ventricular Remodeling

Keywords

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Myocardial infarction Ventricular remodeling Matrix metalloproteinases Doxycycline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxycycline

Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Doxycycline 100 mg bid for seven days after enrollment

Standard Therapy

Pts with AMI treated with Primary PCI and current medical therapy

Group Type ACTIVE_COMPARATOR

Current medical therapy for AMI

Intervention Type DRUG

Current medical therapy for AMI

Interventions

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Doxycycline

Doxycycline 100 mg bid for seven days after enrollment

Intervention Type DRUG

Current medical therapy for AMI

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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David Antoniucci

MD

Responsibility Role PRINCIPAL_INVESTIGATOR