Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling
Information source: Careggi Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction; Ventricular Remodeling
Intervention: Doxycycline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Careggi Hospital Official(s) and/or principal investigator(s):
Giampaolo Cerisano, MD, Principal Investigator, Affiliation: Careggi Hospital, Florence, Italy
David Antoniucci, MD, Study Director, Affiliation: Careggi Hospital, Florence, Italy
Piergiovanni Buonamici, MD, Study Chair, Affiliation: Careggi Hospital, Florence, Italy
Emilio V Dovellini, MD, Study Chair, Affiliation: Careggi Hospital, Florence, Italy
Alberto Santini, MD, Study Chair, Affiliation: Careggi Hospital, Florence, Italy
Umberto Signorini, MD, Study Chair, Affiliation: Careggi Hospital, Florence, Italy
Nazario Carrabba, MD, Study Chair, Affiliation: Careggi Hospital, Florence, Italy
Paolo D Pucci, MD, Study Chair, Affiliation: Careggi Hospital, Florence, Italy
Overall contact:
Piergiovanni Buonamici, MD, Phone: +39-055-410752, Email: carddept@tin.it
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.
Clinical Details
Official title: Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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
Secondary outcome: Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Piergiovanni Buonamici, MD, Phone: +39-055-410752, Email: carddept@tin.it
Careggi Hospital, Department of Heart and Vessels, Florence 50100, Italy; Recruiting
Piergiovanni Buonamici, MD, Phone: +39-055-410752, Email: carddept@tin.it
Additional Information
Starting date: May 2007
Ending date: November 2009
Last updated: May 31, 2007
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