Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-30 @ 8:42 PM
Study NCT ID:
NCT00469261
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2007-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-24', 'studyFirstSubmitDate': '2007-05-03', 'studyFirstSubmitQcDate': '2007-05-03', 'lastUpdatePostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the time course of MMPs and their inhibitors in relation to left ventricular remodeling', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Ventricular remodeling', 'Matrix metalloproteinases', 'Doxycycline'], 'conditions': ['Myocardial Infarction', 'Left Ventricular Remodeling']}, 'referencesModule': {'references': [{'pmid': '24104875', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.\n\nVarious 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction\n* Left ventricular ejection fraction less than 40%\n\nExclusion Criteria:\n\n* No written consensus\n* Allergy to tetracycline\n* Mechanical complication of AMI\n* Previous myocardial infarction\n* Valvular and/or myocardiopathy known or suspected\n* Renal failure (creatinine above 2 mg/dL)\n* Connective tissue disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00469261', 'acronym': 'TIPTOP', 'briefTitle': 'Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling', 'organization': {'class': 'OTHER', 'fullName': 'Careggi Hospital'}, 'officialTitle': 'Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study', 'orgStudyIdInfo': {'id': 'TIP-TOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doxycycline', 'description': 'Active drug 100 mg bid for seven days in pts with AMI treated with Primary PCI and current medical therapy', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'description': 'Pts with AMI treated with Primary PCI and current medical therapy', 'interventionNames': ['Drug: Current medical therapy for AMI']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'description': 'Doxycycline 100 mg bid for seven days after enrollment', 'armGroupLabels': ['Doxycycline']}, {'name': 'Current medical therapy for AMI', 'type': 'DRUG', 'description': 'Current medical therapy for AMI', 'armGroupLabels': ['Standard Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giampaolo Cerisano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'David Antoniucci, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Piergiovanni Buonamici, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Emilio V Dovellini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Alberto Santini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Umberto Signorini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Nazario Carrabba, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Paolo D Pucci, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital, Florence, Italy'}, {'name': 'Renato Valenti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Careggi Hospital , Florence, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Careggi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'David Antoniucci', 'investigatorAffiliation': 'Careggi Hospital'}}}}