NCT00469261

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

4.3 years

First QC Date

May 3, 2007

Last Update Submit

September 24, 2012

Conditions

Myocardial InfarctionLeft Ventricular Remodeling

Keywords

Myocardial infarctionVentricular remodelingMatrix metalloproteinasesDoxycycline

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

Doxycycline

EXPERIMENTAL

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

Drug: Doxycycline

Standard Therapy

ACTIVE COMPARATOR

Pts with AMI treated with Primary PCI and current medical therapy

Drug: Current medical therapy for AMI

Interventions

DoxycyclineDRUG

Doxycycline 100 mg bid for seven days after enrollment

Doxycycline
Current medical therapy for AMIDRUG

Current medical therapy for AMI

Standard Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction
  • Left ventricular ejection fraction less than 40%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cerisano G, Buonamici P, Valenti R, Sciagra 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.

    PMID: 24104875DERIVED

MeSH Terms

Conditions

Myocardial InfarctionVentricular Remodeling

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Giampaolo Cerisano, MD

    Careggi Hospital, Florence, Italy

    PRINCIPAL INVESTIGATOR

  • David Antoniucci, MD

    Careggi Hospital, Florence, Italy

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 25, 2012

Record last verified: 2012-09