Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT01556659
Status:
TERMINATED
Last Update Posted:
2024-04-25
First Post:
2012-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LV Thrombus After Acute AMI: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.', 'timeFrame': '6 months relative to baseline', 'description': 'Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by Magnetic Resonance Imaging.'}], 'secondaryOutcomes': [{'measure': 'The presence of new cerebral micro-bleeds assessed by MRI', 'timeFrame': 'At 6 months and 12 months relative to baseline'}, {'measure': 'Occurrence of major and minor bleeding', 'timeFrame': 'At 6 and 12 months relative to baseline'}, {'measure': 'Neurological status', 'timeFrame': 'At 6 and 12 months relative to baseline'}, {'measure': 'Quality of life using a validated checklist', 'timeFrame': 'At 6 and 12 months relative to baseline'}, {'measure': 'Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism', 'timeFrame': 'At 6 and 12 months relative to baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Left ventricular thrombus', 'Acute myocardial infarction', 'Anticoagulation'], 'conditions': ['Ventricular Thrombosis Mural Following Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST segment elevation myocardial infarction (STEMI). It is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K antagonist treatment in these patients. However patients with STEMI nowadays undergo primary percutaneous coronary intervention (PCI) with coronary stent placement and consequently require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are currently treated with triple antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral. The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to address this issue.\n\nDesign: A multicenter, prospective, randomized, two non-inferiority trial. The objective of the study is to determine in a randomized fashion the risks and benefits of the addition of vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline Magnetic Resonance Imaging (MRI).', 'detailedDescription': 'Design: A multicenter, prospective, randomized, non-inferiority trial with blinded evaluation of endpoints\n\nObjective: The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation\n\nPatients: Patients with acute myocardial infarction treated with primary PCI and LV thrombus on baseline echocardiography or baseline Magnetic Resonance Imaging. (MRI)\n\nMethods: After written informed consent has been obtained, echocardiography and MRI are performed between 7-12 days after PCI. When LV thrombus is present on baseline MRI, patients are randomized to\n\n1. Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent,) and vitamin K antagonist (goal INR is 2.0 to 3.0))\n2. Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d).\n\nPrimary Endpoint: Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.\n\nSecondary Endpoints: The secondary endpoints as assessed at 6 and 12 months are:\n\n* the composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism\n* presence of new cerebral mirco-bleeds\n* the occurrence of major and minor bleeding\n* neurological status and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected Left Ventricular thrombus on echocardiography or routine Magnetic Resonance Imaging\n* Ongoing treatment with dual antiplatelet therapy according to ESC/ACC-AHA guidelines at the time of randomization.\n\nExclusion Criteria:\n\n* Younger than 18\n* Clinically or hemodynamically unstable\n* Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months\n* Previous stroke or transient ischemic attack\n* Scheduled for major surgery (including Coronary Artery Bypass Grafting) during the course of the study\n* Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists\n* Contra-indication for vitamin K antagonist treatment\n* Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study\n* Congenital cardiac disease\n* Presence of supraventricular or ventricular arrhythmias\n* Expected candidate for ICD implantation with the next 6 months\n* Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation 5 30mL/min)\n* Known or symptomatic brain disease (such as brain tumor)\n* Women who are pregnant.\n* Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging (such as pacemaker, cerebrovascular clips, known contrast allergy, claustrophobia)\n* Follow-up impossible (for example no fixed abode)'}, 'identificationModule': {'nctId': 'NCT01556659', 'briefTitle': 'LV Thrombus After Acute AMI: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens', 'orgStudyIdInfo': {'id': '2011-004265-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'vitamin K antagonist +', 'description': 'Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day) and vitamin K antagonist (acenocoumarol)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin K antagonist -', 'description': 'Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day)', 'interventionNames': ['Drug: Absence of vitamin K antagonist']}], 'interventions': [{'name': 'Absence of vitamin K antagonist', 'type': 'DRUG', 'otherNames': ['warfarin'], 'description': 'Dual anti-platelet therapy', 'armGroupLabels': ['vitamin K antagonist -']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Jan J Piek, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'VU University of Amsterdam', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jan Piek', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}