Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-28 @ 7:35 PM
Study NCT ID:
NCT01155635
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2010-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carvedilol Post-intervention Long-term Administration in Large-scale Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-25', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '6-year', 'description': 'Death from any reason'}, {'measure': 'Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization', 'timeFrame': '6-year'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '6-year'}, {'measure': 'Sudden cardiac death', 'timeFrame': '6-year'}, {'measure': 'Cardiovascular death', 'timeFrame': '6-year'}, {'measure': 'Myocardial infarction', 'timeFrame': '6-year'}, {'measure': 'Acute coronary syndrome', 'timeFrame': '6-year'}, {'measure': 'Sustained ventricular tachycardia or ventricular fibrillation', 'timeFrame': '6-year'}, {'measure': 'Heart failure hospitalization', 'timeFrame': '6-year'}, {'measure': 'Stent thrombosis', 'timeFrame': '6-year', 'description': 'Stent thrombosis defined by Academic Research Consortium'}, {'measure': 'Target-vessel revascularization', 'timeFrame': '6-year'}, {'measure': 'Clinically-driven target-lesion revascularization', 'timeFrame': '6-year'}, {'measure': 'Any coronary revascularization', 'timeFrame': '6-year'}, {'measure': 'Any clinically-driven coronary revascularization', 'timeFrame': '6-year'}, {'measure': 'Coronary artery bypass grafting', 'timeFrame': '6-year'}, {'measure': 'Stroke', 'timeFrame': '6-year', 'description': 'Any ischemic and hemorrhagic strokes excluding transient ischemic attacks'}, {'measure': 'Worsening of angina due to coronary spasm', 'timeFrame': '6-year'}, {'measure': 'Bleeding complications', 'timeFrame': '6-year', 'description': 'Bleeding complications defined by GUSTO and TIMI definitions'}, {'measure': 'Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization', 'timeFrame': '6-year'}, {'measure': 'Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization', 'timeFrame': '6-year'}, {'measure': 'Composite of cardiovascular death, myocardial infarction, stroke', 'timeFrame': '6-year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Adrenergic beta-Antagonists', 'Percutaneous coronary intervention'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '37245250', 'type': 'DERIVED', 'citation': 'Amano M, Izumi C, Watanabe H, Ozasa N, Morimoto T, Bingyuan B, Suwa S, Miyake M, Tamura T, Nakagawa Y, Kadota K, Inuzuka Y, Minamimoto Y, Furukawa Y, Kaji S, Suzuki T, Akao M, Inada T, Kimura T; CAPITAL-RCT Investigators. Effects of Long-Term Carvedilol Therapy in Patients With ST-Segment Elevation Myocardial Infarction and Mildly Reduced Left Ventricular Ejection Fraction. Am J Cardiol. 2023 Jul 15;199:50-58. doi: 10.1016/j.amjcard.2023.04.042. Epub 2023 May 26.'}, {'pmid': '30153268', 'type': 'DERIVED', 'citation': 'Watanabe H, Ozasa N, Morimoto T, Shiomi H, Bingyuan B, Suwa S, Nakagawa Y, Izumi C, Kadota K, Ikeguchi S, Hibi K, Furukawa Y, Kaji S, Suzuki T, Akao M, Inada T, Hayashi Y, Nanasato M, Okutsu M, Kametani R, Sone T, Sugimura Y, Kawai K, Abe M, Kaneko H, Nakamura S, Kimura T; CAPITAL-RCT investigators. Long-term use of carvedilol in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. PLoS One. 2018 Aug 28;13(8):e0199347. doi: 10.1371/journal.pone.0199347. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.', 'detailedDescription': 'Beta-blocker therapy is recommended after ST-segment elevation acute myocardial infarction (STEMI) in the current guidelines although its efficacy in those patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. The purpose of this study is to evaluate whether beta-blocker, carvedilol improves 6-year clinical outcomes in patients with STEMI and preserved left ventricular ejection fraction after primary PCI. The design of this study is multicenter, open-label, randomized controlled trial enrolling 1300 patients without any exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with STEMI after primary PCI\n* Patients with left ventricular ejection fraction more than or equal to 40%\n\nExclusion Criteria:\n\n* Patients with left ventricular ejection fraction less than 40%\n* Patients with contraindication for beta-blocker\n* Patients with implantable cardioverter defibrillators\n* Patients with end-stage malignancy'}, 'identificationModule': {'nctId': 'NCT01155635', 'acronym': 'CAPITAL-RCT', 'briefTitle': 'Carvedilol Post-intervention Long-term Administration in Large-scale Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University, Graduate School of Medicine'}, 'officialTitle': 'Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'C-417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Beta-blocker', 'description': 'Use of Carvedilol with any dose', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non Beta-blocker', 'description': 'No use of Carvedilol', 'interventionNames': ['Drug: No Carvedilol']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'description': 'Use of Carvedilol with any dose', 'armGroupLabels': ['Beta-blocker']}, {'name': 'No Carvedilol', 'type': 'DRUG', 'description': 'No use of Carvedilol', 'armGroupLabels': ['Non Beta-blocker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Division of Cardiology, Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Takeshi Kimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeshi Morimoto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Takeshi Morimoto', 'investigatorAffiliation': 'Kyoto University, Graduate School of Medicine'}}}}