Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
Study NCT ID:
NCT07269366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 358}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2034-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2034-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations', 'timeFrame': '4 years', 'description': 'Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity'}], 'secondaryOutcomes': [{'measure': 'Individual components of the primary endpoint', 'timeFrame': '4 years', 'description': 'Analysis of each component of the primary endpoint separately - all-cause mortality, non-procedural myocardial infarction, stroke, unplanned revascularization, and heart failure hospitalizations.'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '4 years', 'description': 'Death due to cardiovascular causes'}, {'measure': 'Periprocedural myocardial infarction', 'timeFrame': 'Within 30 days post-procedure', 'description': 'Myocardial infarction occurring during or within 30 days after the index revascularization procedure.'}, {'measure': 'Target vessel and target lesion revascularization', 'timeFrame': '4 years', 'description': 'Any repeat revascularization of the initially treated coronary vessel or lesion.'}, {'measure': 'Change in quality of life - Kansas City Cardiomyopathy Questionnaire', 'timeFrame': 'at 1 and 4 years (compared to baseline)', 'description': 'Change in patient-reported quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is scored 0-100 per domain, with higher scores indicating better health status. A positive change from baseline reflects improvement. A ≥5-point change is considered clinically meaningful.'}, {'measure': 'Changes in quality of life - Seattle Angina Questionnaire', 'timeFrame': 'at 1 and 4 years (compared to baseline)', 'description': 'Change in patient-reported quality of life assessed using the Seattle Angina Questionnaire (SAQ). The SAQ is scored in 5 domains from 0-100 per domain, with higher scores indicating fewer symptoms and better health status. A change of ≥5 points is generally considered clinically meaningful.'}, {'measure': 'Cost-effectiveness', 'timeFrame': '4 years', 'description': 'Cost-effectiveness analysis comparing CABG and PCI, expressed as quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery', 'coronary artery disease', 'heart failure', 'low ejection fraction', 'hfref', 'cabg', 'coronary artery bypass graft', 'pci', 'revascularization'], 'conditions': ['Coronary Artery Disease', 'Coronary Artery Disease (CAD)', 'Multivessel Coronary Artery Disease', 'CABG', 'CABG in Low EF', 'Heart Failure', 'PCI', 'Revascularization']}, 'descriptionModule': {'briefSummary': 'This randomized multicenter trial compares coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in 358 patients with ischemic left ventricular dysfunction and multivessel coronary disease. The study evaluates differences in survival, major cardiovascular events, and quality of life over 4 years, and contributes to the international STICH 3.0 collaboration assessing long-term outcomes.', 'detailedDescription': 'Patients with ischemic left ventricular systolic dysfunction (iLVSD) and multivessel coronary artery disease (CAD) have a poor prognosis. Coronary artery bypass grafting (CABG) has been shown to improve long-term survival in this population compared to medical therapy alone. However, CABG carries higher short-term risks, leading to underutilization in older and comorbid patients. In contrast, percutaneous coronary intervention (PCI) is frequently performed due to perceived lower procedural risk, despite limited evidence supporting its benefit in patients with LV dysfunction. Previous studies comparing PCI with medical therapy excluded patients with clear indications for revascularization, such as those with significant angina or recent acute coronary syndrome, leaving uncertainty about the optimal treatment strategy.\n\nThe STICH 3.0-NL trial is a prospective, randomized, controlled, open-label, multicenter study designed to compare CABG and PCI in patients with iLVSD (LVEF \\<40%) and multivessel CAD who are candidates for coronary revascularization. A total of 358 patients will be enrolled and randomized in a 1:1 ratio to undergo CABG or PCI, aiming for full revascularization.\n\nThe primary endpoint is a hierarchical composite of all-cause mortality, recurrent major adverse cardiovascular events (MACE: non-procedural myocardial infarction, stroke, or unplanned revascularization), and recurrent hospitalizations for heart failure at 4 years. Secondary endpoints include the individual components of the primary endpoint, cardiovascular mortality, periprocedural myocardial infarction, target vessel and lesion revascularization, changes in quality of life (Seattle Angina Questionnaire and KCCQ), and cost-effectiveness expressed as QALY and ICER.\n\nThe STICH 3.0-NL trial will contribute approximately 10% of the total cohort to the international STICH 3.0 collaboration, enabling long-term analyses of all-cause mortality at 5 and 10 years and providing critical evidence to guide revascularization strategies in patients with ischemic cardiomyopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* LVEF≤ 40%\n* Angina pectoris, CCS≥2 and/or hospitalization for ACS or heart failure within 1 year prior to randomization\n* Multivessel CAD (2-3 vessel-disease with coronary lesions \\>70% and involvement of proximal LAD, and/or LM stenosis of \\>50%). Target vessels are determined by the local Heart Time\n* Clinical and angiographical characteristics suitable for isolated coronary revascularization both by CABG or PCI according to the judgment of the local Heart Team\n* Written informed consent\n\nExclusion Criteria:\n\n* ACS \\< 48 hours before randomization\n* Valvular/structural heart disease requiring intervention\n* Contra-indications to DAPT\n* Non-cardiac condition with life expectancy \\< 1 year\n* Previous CABG\n* Decompensated HF at the time of inclusion'}, 'identificationModule': {'nctId': 'NCT07269366', 'acronym': 'STICH 3*0-NL', 'briefTitle': 'Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function', 'orgStudyIdInfo': {'id': 'NL-009839'}, 'secondaryIdInfos': [{'id': '01-001-2024-0545', 'type': 'OTHER_GRANT', 'domain': 'Dutch Heart Foundation (Hartstichting)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CABG (surgery)', 'description': 'Patients randomized to CABG will receive CABG - aiming for full revascularization', 'interventionNames': ['Procedure: CABG']}, {'type': 'OTHER', 'label': 'PCI (percutaneous)', 'description': 'Patients randomized to PCI will receive PCI - aiming for full revascularization', 'interventionNames': ['Procedure: PCI']}], 'interventions': [{'name': 'CABG', 'type': 'PROCEDURE', 'description': 'CABG (coronary artery bypass grafting)', 'armGroupLabels': ['CABG (surgery)']}, {'name': 'PCI', 'type': 'PROCEDURE', 'description': 'PCI (percutaneous coronary intervention)', 'armGroupLabels': ['PCI (percutaneous)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Erik Lipsic, Dr', 'role': 'CONTACT', 'email': 'e.lipsic@umcg.nl', 'phone': '+31 50 3612355'}, {'name': 'Ruben R. De With, Dr', 'role': 'CONTACT', 'email': 'r.r.de.with@umcg.nl', 'phone': '+31 50 3612355'}], 'overallOfficials': [{'name': 'Erik Lipsic, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}