Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 11:19 AM
Study NCT ID:
NCT04148820
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2019-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D020913', 'term': 'Perindopril'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into two parallel groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Outcome Event (MACE)', 'timeFrame': 'Up to 1 year', 'description': 'The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease'], 'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers.\n\nUncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.\n\nThe investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.', 'detailedDescription': 'Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers.\n\nThese drugs are usually given at different timetables. Recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted.\n\nUncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.\n\nThe investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIschemic heart disease, willing to participate, compliance to medical therapy\n\nExclusion Criteria:\n\nPatients with acute coronary syndrome; pregnancy'}, 'identificationModule': {'nctId': 'NCT04148820', 'acronym': 'ONCE', 'briefTitle': 'One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease: An Open Label, Randomized, Multicenter Study', 'orgStudyIdInfo': {'id': '2019/D/789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Once daily drug administration', 'description': 'Patients will be given cardiovascular drugs once daily', 'interventionNames': ['Drug: Aspirin, Atorvastatin, Perindopril']}, {'type': 'EXPERIMENTAL', 'label': 'Twice daily drug administration', 'description': 'Patients will be given cardiovascular drugs twice daily', 'interventionNames': ['Drug: Aspirin, Atorvastatin, Perindopril']}], 'interventions': [{'name': 'Aspirin, Atorvastatin, Perindopril', 'type': 'DRUG', 'description': 'Cardiovascular drugs will be administered all together every day at the same time', 'armGroupLabels': ['Once daily drug administration', 'Twice daily drug administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Rome', 'country': 'Italy', 'facility': 'San Raffaele Pisana', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Sapienza University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Francesco Pelliccia', 'role': 'CONTACT', 'email': 'f.pelliccia@mclink.it', 'phone': '+390633062615'}], 'overallOfficials': [{'name': 'Giuseppe Marazzi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Raffaele Pisana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Francesco Pelliccia', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}