Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-12 @ 10:58 AM
Study NCT ID:
NCT05824520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1066}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events (MACE)', 'timeFrame': '1 year', 'description': 'A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '1 year', 'description': 'All-cause death and cardiac death.'}, {'measure': 'MI', 'timeFrame': '1 year', 'description': 'Target vessel related and non-target vessel related MI.'}, {'measure': 'Revascularization', 'timeFrame': '1 year', 'description': 'Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.'}, {'measure': 'Stroke', 'timeFrame': '1 year', 'description': 'Stroke (ischemic and hemorrhagic).'}, {'measure': 'Cost-effectiveness analysis', 'timeFrame': '1 year', 'description': 'Medical expenses of treatment and follow-up.'}, {'measure': 'Quality of life assessed by Seattle Angina Questionnaire', 'timeFrame': '1 year', 'description': 'Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire.'}, {'measure': 'MACE', 'timeFrame': '1 month, 2 years, 3 years, 5 years', 'description': 'A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Myocardial Ischaemia']}, 'descriptionModule': {'briefSummary': 'The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.', 'detailedDescription': 'ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80\n* Patients with chronic coronary syndromes\n* Signed written informed consent\n\nExclusion Criteria:\n\n* The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \\[e.g. rash\\] may be enrolled)\n* Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)\n* Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)\n* Inability or unwillingness to undergo CT scan or coronary angiography\n* Patients on hemodialysis or with severe hepatic or renal insufficiency\n* Left main coronary artery stenosis ≥ 50%\n* Target vessel total occlusion\n* Pregnancy or intention to become pregnant during the course of the trial\n* Patients with a life expectancy less than 2 years'}, 'identificationModule': {'nctId': 'NCT05824520', 'acronym': 'ACCURATE II', 'briefTitle': 'Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Coronary Computed Tomography-Derived Fraction Flow Reserve (FFR)-Guided Invasive Treatment Strategy (ITS) Versus Optimal Medical Therapy (OMT) Alone in Patient With Chronic Coronary Syndrome', 'orgStudyIdInfo': {'id': '2023-0318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-derived FFR guided-ITS group', 'description': 'CT-derived FFR≤0.8; ITS plus OMT', 'interventionNames': ['Other: ITS plus OMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical therapy group', 'description': 'CT-derived FFR≤0.8; OMT alone', 'interventionNames': ['Other: OMT']}], 'interventions': [{'name': 'ITS plus OMT', 'type': 'OTHER', 'description': 'Invasive treatment strategy plus optimal medical therapy', 'armGroupLabels': ['CT-derived FFR guided-ITS group']}, {'name': 'OMT', 'type': 'OTHER', 'description': 'Optimal medical therapy alone', 'armGroupLabels': ['Medical therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Jun Jiang, MD', 'role': 'CONTACT', 'email': 'jiang-jun@zju.edu.cn'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': "Jian'an Wang, MD", 'role': 'CONTACT', 'email': 'wangjianan111@zju.edu.cn', 'phone': '+(86)(571) 87784808'}], 'overallOfficials': [{'name': "Jian'an Wang, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}