Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling (TIPTOP)
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|ClinicalTrials.gov Identifier: NCT00469261|
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : September 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Left Ventricular Remodeling||Drug: Doxycycline Drug: Current medical therapy for AMI||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy
Doxycycline 100 mg bid for seven days after enrollment
Active Comparator: Standard Therapy
Pts with AMI treated with Primary PCI and current medical therapy
Drug: Current medical therapy for AMI
Current medical therapy for AMI
- 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 ]
- Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469261
|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|