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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00469261 |
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Date of registration:
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03/05/2007 |
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Primary sponsor: |
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Public title:
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Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling
TIPTOP |
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Scientific title:
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Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00469261 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Renato Valenti, MD |
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Address:
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Affiliation:
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Careggi Hospital , Florence, Italy |
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Name:
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Alberto Santini, MD |
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Email:
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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David Antoniucci, MD |
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Address:
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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Emilio V Dovellini, MD |
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Address:
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Email:
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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Giampaolo Cerisano, MD |
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Address:
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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Nazario Carrabba, MD |
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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Paolo D Pucci, MD |
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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Piergiovanni Buonamici, MD |
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Address:
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Name:
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Umberto Signorini, MD |
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Address:
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Affiliation:
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Careggi Hospital, Florence, Italy |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Left Ventricular Remodeling
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Myocardial Infarction
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Intervention(s)
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Drug: Current medical therapy for AMI
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Drug: Doxycycline
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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