Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 3, 2007

Last Updated Date

May 31, 2007

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00469261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling

Official Title ^†

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Myocardial Infarction
Ventricular Remodeling

Intervention ^†

Drug: Doxycycline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

110

Estimated Completion Date

November 2009

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Piergiovanni Buonamici, MD

+39-055-410752

carddept@tin.it

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00469261

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Careggi Hospital

Collaborators ^††

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

Information Provided By

Careggi Hospital

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.