Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling (TIPTOP)

September 24, 2012 updated by: David Antoniucci, Careggi Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Doxycycline
Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy
Drug: Doxycycline
Doxycycline 100 mg bid for seven days after enrollment
ACTIVE_COMPARATOR: Standard Therapy
Pts with AMI treated with Primary PCI and current medical therapy
Drug: Current medical therapy for AMI
Current medical therapy for AMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 group
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Careggi Hospital

Investigators

  • Principal Investigator: Giampaolo Cerisano, MD, Careggi Hospital, Florence, Italy
  • Study Director: David Antoniucci, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Piergiovanni Buonamici, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Emilio V Dovellini, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Alberto Santini, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Umberto Signorini, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Nazario Carrabba, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Paolo D Pucci, MD, Careggi Hospital, Florence, Italy
  • Study Chair: Renato Valenti, MD, Careggi Hospital , Florence, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (ESTIMATE)

May 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIP-TOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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