Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-11 @ 6:51 AM
Study NCT ID:
NCT02419833
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000072658', 'term': 'Non-ST Elevated 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of all-cause death or myocardial reinfarction', 'timeFrame': 'within 30 days of randomization'}], 'secondaryOutcomes': [{'measure': 'Composite of all-cause death, myocardial reinfarction or recurrent ischemia', 'timeFrame': 'within 30 days of randomization'}, {'measure': 'All-cause mortality', 'timeFrame': 'within 30 days, 1, 3 and 5 years after randomization'}, {'measure': 'Myocardial reinfarction', 'timeFrame': 'within 30 days, 1, 3 and 5 years after randomization'}, {'measure': 'Stroke', 'timeFrame': 'within 30 days, 1, 3 and 5 years after randomization'}, {'measure': 'Recurrent ischemia', 'timeFrame': 'within 30 days of randomization'}, {'measure': 'Major bleeding', 'timeFrame': 'within 30 days, 1, 3 and 5 years after randomization'}, {'measure': 'Duration of index hospitalization', 'timeFrame': 'at 30-day follow-up, the duration of hospital stay is assessed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-STEMI', 'immediate', 'delayed', 'PCI'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '26777321', 'type': 'DERIVED', 'citation': 'Milosevic A, Vasiljevic-Pokrajcic Z, Milasinovic D, Marinkovic J, Vukcevic V, Stefanovic B, Asanin M, Dikic M, Stankovic S, Stankovic G. Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients: The RIDDLE-NSTEMI Study. JACC Cardiovasc Interv. 2016 Mar 28;9(6):541-9. doi: 10.1016/j.jcin.2015.11.018. Epub 2016 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved.\n\nImmediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure.\n\nThe purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. episode of chest pain occurring no longer than 24 hours prior to admission\n2. elevation of cardiac troponin I above the upper limit of normal (ULN)\n3. new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads\n\nExclusion Criteria:\n\n1. age \\< 18 years\n2. persistent ST-segment elevation\n3. hemodynamic instability\n4. cardiogenic shock on admission\n5. life-threatening ventricular arrhythmias on admission\n6. refractory angina on admission\n7. active bleeding\n8. any contraindication for the use of dual antiplatelet therapy (DAPT)\n9. presence of comorbidities with life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT02419833', 'acronym': 'RIDDLE-NSTEMI', 'briefTitle': 'Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Centre of Serbia'}, 'officialTitle': 'Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': '440/VII/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate invasive intervention', 'description': 'Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission', 'interventionNames': ['Procedure: Immediate invasive intervention', 'Device: Coronary artery stenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed invasive intervention', 'description': 'Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and within 2-72 hours of admission', 'interventionNames': ['Procedure: Delayed invasive intervention', 'Device: Coronary artery stenting']}], 'interventions': [{'name': 'Immediate invasive intervention', 'type': 'PROCEDURE', 'description': 'Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission', 'armGroupLabels': ['Immediate invasive intervention']}, {'name': 'Delayed invasive intervention', 'type': 'PROCEDURE', 'description': 'Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission', 'armGroupLabels': ['Delayed invasive intervention']}, {'name': 'Coronary artery stenting', 'type': 'DEVICE', 'description': 'Implantation of coronary stents', 'armGroupLabels': ['Delayed invasive intervention', 'Immediate invasive intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Centre of Serbia, Department of Cardiology', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Goran Stankovic, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Centre of Serbia'}, {'name': 'Aleksandra Milosevic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Centre of Serbia'}, {'name': 'Zorana Vasiljevic, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Centre of Serbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Centre of Serbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Aleksandra Milosevic', 'investigatorAffiliation': 'Clinical Centre of Serbia'}}}}