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Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling (TIPTOP)
This study is currently recruiting participants.
Verified by Careggi Hospital, May 2007
First Received: May 3, 2007   Last Updated: May 31, 2007   History of Changes
Sponsored by: Careggi Hospital
Information provided by: Careggi Hospital
ClinicalTrials.gov Identifier: NCT00469261
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Ventricular Remodeling
Drug: Doxycycline
Phase III

MedlinePlus related topics: Heart Attack
Drug Information available for: Tetracycline Tetracycline hydrochloride Doxycycline Doxycycline hyclate Doxycycline calcium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study

Further study details as provided by Careggi Hospital:

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 ]

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

Estimated Enrollment: 110
Study Start Date: May 2007
Estimated Study Completion Date: November 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469261

Contacts
Contact: Piergiovanni Buonamici, MD +39-055-410752 carddept@tin.it

Locations
Italy
Careggi Hospital, Department of Heart and Vessels Recruiting
Florence, Italy, 50100
Contact: Piergiovanni Buonamici, MD     +39-055-410752     carddept@tin.it    
Sponsors and Collaborators
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
  More Information

No publications provided

Study ID Numbers: arcard2007/002
Study First Received: May 3, 2007
Last Updated: May 31, 2007
ClinicalTrials.gov Identifier: NCT00469261     History of Changes
Health Authority: Italy: Ministry of Health

Keywords provided by Careggi Hospital:
Myocardial infarction
Ventricular remodeling
Matrix metalloproteinases
Doxycycline

Study placed in the following topic categories:
Antimalarials
Anti-Bacterial Agents
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Tetracycline
Infarction
Myocardial Infarction
Doxycycline

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Ischemia
Tetracycline
Pharmacologic Actions
Antimalarials
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Antiparasitic Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction
Doxycycline

ClinicalTrials.gov processed this record on May 06, 2009