Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT01694459
Status:
UNKNOWN
Last Update Posted:
2012-09-27
First Post:
2012-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEDICA (Dose of HEparin During Coronary Angioplasty) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-26', 'studyFirstSubmitDate': '2012-09-23', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Major bleeding', 'timeFrame': '30 days', 'description': 'Major bleeding according to STEEPLE criteria'}], 'primaryOutcomes': [{'measure': 'MACE + stent thrombosis + major bleeding (TIMI definition)', 'timeFrame': '30 days', 'description': 'MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': '30 days', 'description': 'MACE = death, myocardial infarction, target vessel revascularization'}, {'measure': 'Major Bleeding', 'timeFrame': '30 days', 'description': 'Major bleeding according to TIMI criteria'}, {'measure': 'Stent thrombosis', 'timeFrame': '30 days', 'description': 'Stent thrombosis (definite or probable according to ARC criteria)'}, {'measure': 'CK-MB increase', 'timeFrame': '30 days', 'description': 'Any CK MB increase \\>3 times upper limit of normal or \\>50% baseline levels (if baseline levels already \\>then upper limit of normal)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['angioplasty', 'heparin', 'trial'], 'conditions': ['Stable Angina', 'Angina, Unstable', 'Non-ST Elevation (NSTEMI) Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents.\n\nThus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.', 'detailedDescription': '* Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose heparin. the study will include "all-comers" (patients with either stable angina or acute coronary syndromes); only patients with ST-elevation myocardial infarction will be excluded.\n* An ACT (activated clotting time) will be performed after the initial bolus of heparin: for the standard dose group the target ACT will be \\> 300 sec. (as recommended by guidelines) while for the low-dose the target ACT will be \\> 180 sec.\n\nAim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.\n* Mandatory pretreatment with aspirin and clopidogrel\n\nExclusion Criteria:\n\n* ST elevation myocardial infarction\n* Coronary interventions with rotational atherectomy\n* Coronary interventions on chronic total occlusions (CTO)'}, 'identificationModule': {'nctId': 'NCT01694459', 'acronym': 'DEDICA', 'briefTitle': 'DEDICA (Dose of HEparin During Coronary Angioplasty) Trial', 'organization': {'class': 'OTHER', 'fullName': 'San Filippo Neri General Hospital'}, 'officialTitle': 'Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)', 'orgStudyIdInfo': {'id': '596-2012-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose heparin', 'description': 'Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \\> 300 sec. during the procedure', 'interventionNames': ['Drug: Standard dose heparin']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose heparin', 'description': 'Bolus of 50 UI/Kg heparin with a target ACT during the procedure of \\>200 sec.', 'interventionNames': ['Drug: Low-dose heparin']}], 'interventions': [{'name': 'Low-dose heparin', 'type': 'DRUG', 'otherNames': ['50 UI/Kg bolus heparin'], 'description': 'Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions', 'armGroupLabels': ['Low-dose heparin']}, {'name': 'Standard dose heparin', 'type': 'DRUG', 'otherNames': ['100 Ui/Kg bolus heparin'], 'description': 'Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.', 'armGroupLabels': ['Standard dose heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Pelliccia, MD', 'role': 'CONTACT'}, {'name': 'Carlo Gaudio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rome La Sapienza', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Vincenzo Pasceri, MD', 'role': 'CONTACT', 'email': 'vpasceri@hotmail.com', 'phone': '+39063306', 'phoneExt': '2504'}, {'name': 'Francesco Pelliccia, MD', 'role': 'CONTACT', 'email': 'md4151@mclink.it', 'phone': '+393483392006'}], 'overallOfficials': [{'name': 'Vincenzo Pasceri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'San Filippo Neri Hospital'}, {'name': 'Francesco Pelliccia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Filippo Neri General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Cardiologist', 'investigatorFullName': 'Vincenzo Pasceri', 'investigatorAffiliation': 'San Filippo Neri General Hospital'}}}}