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Trial record 33 of 137 for:    tetracycline

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00469261
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date September 25, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2007)
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  ICMJE
 (submitted: May 3, 2007)
Reduction of LV dilation (six-months vs baseline LV end-diastolic volume index by 2D-echo) more than 50% in the treated group in comparison to the placebo group. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2007)
Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Evaluation of the time-course of MMPs and their inhibitors in relation to left ventricular remodeling. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Left Ventricular Remodeling
Intervention  ICMJE
  • Drug: Doxycycline
    Doxycycline 100 mg bid for seven days after enrollment
  • Drug: Current medical therapy for AMI
    Current medical therapy for AMI
Study Arms  ICMJE
  • Experimental: Doxycycline
    Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy
    Intervention: Drug: Doxycycline
  • Active Comparator: Standard Therapy
    Pts with AMI treated with Primary PCI and current medical therapy
    Intervention: Drug: Current medical therapy for AMI
Publications * Cerisano G, Buonamici P, Valenti R, Sciagrà R, Raspanti S, Santini A, Carrabba N, Dovellini EV, Romito R, Pupi A, Colonna P, Antoniucci D. Early short-term doxycycline therapy in patients with acute myocardial infarction and left ventricular dysfunction to prevent the ominous progression to adverse remodelling: the TIPTOP trial. Eur Heart J. 2014 Jan;35(3):184-91. doi: 10.1093/eurheartj/eht420. Epub 2013 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2007)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00469261
Other Study ID Numbers  ICMJE TIP-TOP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Antoniucci, Careggi Hospital
Study Sponsor  ICMJE Careggi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Careggi Hospital
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP