Myocardial InfarctionPhase 2TIPTOPNCT00469261
Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling
A Phase 2 study testing Doxycycline and Current medical therapy for AMI in people with Myocardial Infarction and Left Ventricular Remodeling, run by Careggi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Left Ventricular Remodeling
- What is being tested?
- Doxycycline and Current medical therapy for AMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction
- Left ventricular ejection fraction less than 40%
Who cannot join
- 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
About this study
Official title: Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study
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.
Read the 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.
- Conditions
- Myocardial Infarction, Left Ventricular Remodeling
- Being tested
- Doxycycline, Current medical therapy for AMI
- Keywords
- Myocardial infarction, Ventricular remodeling, Matrix metalloproteinases, Doxycycline
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 100 mg bid for seven days after enrollment
Current medical therapy for AMIDrug
Current medical therapy for AMI
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy Receives: Drug: Doxycycline |
| Standard Therapy | Active comparator | Pts with AMI treated with Primary PCI and current medical therapy Receives: Drug: Current medical therapy for AMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Antoniucci, Careggi Hospital
- Investigators
- Giampaolo Cerisano, MD, Principal investigator, Careggi Hospital, Florence, ItalyDavid Antoniucci, MD, Study director, Careggi Hospital, Florence, ItalyPiergiovanni Buonamici, MD, Study chair, Careggi Hospital, Florence, ItalyEmilio V Dovellini, MD, Study chair, Careggi Hospital, Florence, ItalyAlberto Santini, MD, Study chair, Careggi Hospital, Florence, ItalyUmberto Signorini, MD, Study chair, Careggi Hospital, Florence, ItalyNazario Carrabba, MD, Study chair, Careggi Hospital, Florence, ItalyPaolo D Pucci, MD, Study chair, Careggi Hospital, Florence, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469261
- Sponsor's protocol ID
- TIP-TOP
- Acronym
- TIPTOP
- Status last verified
- Sep 2012
- First submitted
- 3 May 2007
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24104875
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study
- ClinicalTrials.gov ID
- NCT00469261
- Acronym / sponsor ID
- TIPTOP / TIP-TOP
- Conditions
- Myocardial Infarction, Left Ventricular Remodeling
- Keywords
- Myocardial infarction, Ventricular remodeling, Matrix metalloproteinases, Doxycycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: DoxycyclineActive drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy |
| Standard Therapy | Active comparator | Drug: Current medical therapy for AMIPts with AMI treated with Primary PCI and current medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction
- Left ventricular ejection fraction less than 40%
Key exclusion criteria (8 listed)
- No written consensus
- Allergy to tetracycline
- Mechanical complication of AMI
- Previous myocardial infarction
- Valvular and/or myocardiopathy known or suspected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineDoxycycline 100 mg bid for seven days after enrollment | Drug | Doxycycline |
| Current medical therapy for AMICurrent medical therapy for AMI | Drug | Standard Therapy |
Primary outcome
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
1 secondary outcome
Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
- Derived from this study: PubMed 24104875Cerisano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giampaolo Cerisano, MD principal investigator
Careggi Hospital, Florence, Italy
David Antoniucci, MD study director
Careggi Hospital, Florence, Italy
Piergiovanni Buonamici, MD study chair
Careggi Hospital, Florence, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline and Current medical therapy for AMI in people with Myocardial Infarction and Left Ventricular Remodeling, run by Careggi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.