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

Primary Purpose

Myocardial Infarction, Left Ventricular Remodeling

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Doxycycline

Current medical therapy for AMI

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Ventricular remodeling, Matrix metalloproteinases, Doxycycline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Doxycycline

Standard Therapy

Arm Description

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

Pts with AMI treated with Primary PCI and current medical therapy

Outcomes

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

Secondary Outcome Measures

Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling

Full Information

NCT ID

NCT00469261

First Posted

May 3, 2007

Last Updated

September 24, 2012

Sponsor

Careggi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00469261

Brief Title

Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling

Acronym

TIPTOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Careggi Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Left Ventricular Remodeling

Keywords

Myocardial infarction, Ventricular remodeling, Matrix metalloproteinases, Doxycycline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doxycycline

Arm Type

Experimental

Arm Description

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

Arm Title

Standard Therapy

Arm Type

Active Comparator

Arm Description

Pts with AMI treated with Primary PCI and current medical therapy

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Intervention Description

Doxycycline 100 mg bid for seven days after enrollment

Intervention Type

Drug

Intervention Name(s)

Current medical therapy for AMI

Intervention Description

Current medical therapy for AMI

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: