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Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00469261
Acronym
TIPTOP
Enrollment
110
Registered
2007-05-04
Start date
2007-05-31
Completion date
2011-08-31
Last updated
2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Remodeling, Myocardial Infarction

Keywords

Myocardial infarction, Ventricular remodeling, Matrix metalloproteinases, Doxycycline

Brief summary

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

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.

Interventions

DRUGDoxycycline

Doxycycline 100 mg bid for seven days after enrollment

DRUGCurrent medical therapy for AMI

Current medical therapy for AMI

Sponsors

Careggi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 group6 months

Secondary

MeasureTime frame
Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026