Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-03 @ 10:38 PM
Study NCT ID:
NCT03321032
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2017-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second-generation Drug-eluting Stents in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2017-10-22', 'studyFirstSubmitQcDate': '2017-10-22', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure at 1-year follow-up', 'timeFrame': '12 months', 'description': 'A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12-months follow-up.'}, {'measure': 'Target lesion failure at 2-years follow-up', 'timeFrame': '24 months', 'description': 'A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 24-months follow-up.'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '12 and 24 months'}, {'measure': 'Target vessel myocardial infarction', 'timeFrame': '12 and 24 months'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12 and 24 months'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 and 24 months'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 and 24 months', 'description': 'Academic Research Consortium definitions'}, {'measure': 'Non-target lesion revascularization', 'timeFrame': '12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Diabetes Mellitus', 'Drug-eluting stents', 'Restenosis'], 'conditions': ['Coronary Artery Disease', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32087418', 'type': 'RESULT', 'citation': 'Romaguera R, Salinas P, Brugaletta S, Gomez-Lara J, Diaz JF, Romero MA, Garcia-Blas S, Ocaranza R, Borde P, Jimenez Kockar M, Millan Segovia R, Iniguez A, Alameda M, Trillo R, Lee DH, Martin P, Lopez-Benito M, Frutos A, Moreu J, Hernandez-Hernandez F, Garcia Del Blanco B, Roura G, Rossello X, Pocock SJ, Fernandez-Ortiz A, Sabate M, Gomez-Hospital JA. Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial: Rationale and study design. Am Heart J. 2020 Apr;222:174-182. doi: 10.1016/j.ahj.2020.01.018. Epub 2020 Jan 28. No abstract available.'}, {'pmid': '40562528', 'type': 'DERIVED', 'citation': 'Salinas P, Romaguera R, Gomez-Lara J, Brugaletta S, Gomez-Menchero A, Martin P, Romero M, Garcia-Blas S, Jimenez M, Jimenez VA, Bordes P, Bayon J, Salvatella N, Alameda M, Hyun-Lee D, Trillo-Nouche R, Lopez-Benito M, Frutos A, Moreu J, Garcia Del Blanco B, Mohandes M, Bosa Ojeda F, Hernandez Hernandez F, Pinar-Bermudez E, Jimenez-Quevedo P, Rossello X, Pocock S, Sabate M, Gomez-Hospital JA, Comin-Colet J, Gonzalo N, Fernandez Ortiz A; SUGAR trial Investigators. Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial. Heart. 2025 Nov 25;111(24):1191-1198. doi: 10.1136/heartjnl-2025-325773.'}, {'pmid': '34735004', 'type': 'DERIVED', 'citation': 'Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, Gomez-Menchero A, Romero MA, Garcia-Blas S, Ocaranza R, Bordes P, Kockar MJ, Salvatella N, Jimenez-Diaz VA, Alameda M, Trillo R, Lee DH, Martin P, Lopez-Benito M, Freites A, Pascual-Tejerina V, Hernandez-Hernandez F, Blanco BGD, Mohandes M, Bosa F, Pinar E, Roura G, Comin-Colet J, Fernandez-Ortiz A, Macaya C, Rossello X, Sabate M, Pocock SJ, Gomez-Hospital JA; SUGAR trial investigators. Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial. Eur Heart J. 2022 Mar 31;43(13):1320-1330. doi: 10.1093/eurheartj/ehab790.'}]}, 'descriptionModule': {'briefSummary': 'This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology.\n\nIt is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design.\n\nThe primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria(must meet all):\n\n* Patients ≥18 years who understands the nature of the study and provides written informed consent.\n* Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (\\*)\n* Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).\n* At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).\n\nExclusion Criteria:\n\n* Cardiogenic shock or resuscitation\n* Comorbidity with anticipated life expectancy to 24 months\n* Inability to consent due to mechanical ventilation\n* Pregnant female patient\n* Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count \\<100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)\n* Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).\n* Currently enrolled in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT03321032', 'acronym': 'SUGAR', 'briefTitle': 'Second-generation Drug-eluting Stents in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Society of Cardiology'}, 'officialTitle': 'Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)', 'orgStudyIdInfo': {'id': 'SEC-SUG-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amphilimus-eluting stents', 'description': 'Polymer-free Amphilimus-eluting stents', 'interventionNames': ['Device: Polymer-free amphilimus-eluting stents']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zotarolimus-eluting stents', 'description': 'Biolinx Polymer-based zotarolimus-eluting stents', 'interventionNames': ['Device: Biolinx Polymer-based zotarolimus-eluting stents']}], 'interventions': [{'name': 'Polymer-free amphilimus-eluting stents', 'type': 'DEVICE', 'description': 'Cre8 Evo coronary stent system (CID, Saluggia, Italy)', 'armGroupLabels': ['Amphilimus-eluting stents']}, {'name': 'Biolinx Polymer-based zotarolimus-eluting stents', 'type': 'DEVICE', 'description': 'Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)', 'armGroupLabels': ['Zotarolimus-eluting stents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital San Juan', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Doctor Negrín', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'León', 'country': 'Spain', 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clínica Universidad de Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitario Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Society of Cardiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Rafael Romaguera', 'investigatorAffiliation': 'Spanish Society of Cardiology'}}}}