Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT06353594
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1272}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2035-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure (TLF)', 'timeFrame': '12 months', 'description': 'Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Incidence of all-cause death', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of myocardial infarction', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of cardiovascular death', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of target lesion revascularization', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of stent thrombosis', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of acute vessel closure', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of stroke', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}, {'measure': 'Incidence of bleeding', 'timeFrame': '10 years', 'description': 'Physicians Assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '40412715', 'type': 'DERIVED', 'citation': 'Sanz-Sanchez J, Santos Martinez S, Rumiz Gonzalez E, Oteo Dominguez JF, Tejada Ponce D, Gomez Menchero A, Sanchez Elvira G, Fuertes Ferre G, Rivero Crespo F, Lukic Otanovic A, Diaz Fernandez J, Galindo Fernandez E, Urbano Carrillo C, Salvatella Giralt N, Torres Sanchez M, Garcia Touchard A, Ibanez Cabeza B, Stefanini G, Alfonso Manterola F, Garcia Garcia H, Amat-Santos IJ. Reduced stent strategy versus conventional percutaneous coronary revascularization in patients presenting with STEMI: the COPERNICAN trial. Rev Esp Cardiol (Engl Ed). 2025 May 22:S1885-5857(25)00150-1. doi: 10.1016/j.rec.2025.05.005. Online ahead of print. English, Spanish.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).\n\nRandomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:\n\n* Study group: reduced stent PCI strategy (DCB-based)\n* Control group: conventional PCI strategy (DES-based).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients presenting with STEMI and indication to undergo pPCI.\n\nExclusion Criteria:\n\n* Life expectancy \\<1 year due 1 to non-cardiac disease.\n* Inability to provide informed consent.\n* Cardiogenic shock.\n* Left ventricular ejection fraction \\<15%.\n* Left main disease.\n* Stent thrombosis\n* Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).\n* Patients with chronic total occlusions.\n* Untreatable coronary disease.\n* Non-identified culprit lesion.\n* Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.'}, 'identificationModule': {'nctId': 'NCT06353594', 'acronym': 'COPERNICAN', 'briefTitle': 'Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Fe'}, 'officialTitle': 'Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)', 'orgStudyIdInfo': {'id': 'COPERNICAN TRIAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCB-based', 'description': 'Reduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections \\>type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted.', 'interventionNames': ['Device: Primary PCI']}, {'type': 'NO_INTERVENTION', 'label': 'DES-based', 'description': 'Control group'}], 'interventions': [{'name': 'Primary PCI', 'type': 'DEVICE', 'description': 'Coronary percutaneous revascularization', 'armGroupLabels': ['DCB-based']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge Sanz Sánchez, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Y Politecnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Castelló', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Tejada Ponce, PI', 'role': 'CONTACT'}], 'facility': 'Consorcio Hospitalario Provincial de Castellon', 'geoPoint': {'lat': 41.01149, 'lon': 0.84856}}, {'city': 'Elche', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Paula Tejedor Viñuela, PI', 'role': 'CONTACT'}], 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': "L'Hospitalet de Llobregat", 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Neus Salvatella Giralt, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Sarnago Cebada, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Rivero Crespo, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan F Oteo Domínguez, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristobal Urbano Carrillo, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Regional de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Pamplona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Guillermo Sánchez Elvira, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Seville', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Díaz Fernández, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Tarragona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mauricio Torres Sánchez, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Joan Xxiii de Tarragona', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eva Rumiz González, PI', 'role': 'CONTACT'}], 'facility': 'Consorcio Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio J Amat Santos, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Clinico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Zaragoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonela Lukic Otanovic, PI', 'role': 'CONTACT'}], 'facility': 'Hospital Clinico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Zaragoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Georgina A Fuertes Ferre', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Naiara García Lamas', 'role': 'CONTACT', 'email': 'naiara@pinvestiga.com', 'phone': '634213101'}, {'name': 'Marta Fernández Álvarez', 'role': 'CONTACT', 'email': 'marta@pinvestiga.com', 'phone': '604037828'}], 'overallOfficials': [{'name': 'Jorge Sanz Sánchez, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Fe'}, {'name': 'Ignacio J Amat Santos, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Valladolid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jorge Sanz Sanchez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Interventional cardiologist', 'investigatorFullName': 'Jorge Sanz Sanchez', 'investigatorAffiliation': 'Hospital Universitario La Fe'}}}}