[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06655376":3,"trial-entities:NCT06655376":130,"trial-summary:NCT06655376":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":51,"sex":71,"minimum_age":72,"maximum_age":15,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":86,"locations":89,"central_contacts":122,"overall_officials":125,"references":128,"see_also_links":129},"NCT06655376","AAAV3358","Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device","Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device","RECRUITING","2027-04-01","2026-02","2026-02-27","2024-10-02","Columbia University","OTHER",null,"Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.\n\nThis clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.","Objective: To study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure who are chronically supported with the HeartMate 3 LVAD.\n\nHypothesis: The withdrawal of aspirin from the antithrombotic regimen of HeartMate3 LVAD patients will not adversely affect safety and efficacy and may reduce non-surgical bleeding.\n\nClinical Investigation Design: This is a prospective, randomized, controlled clinical investigation of advanced heart failure patients who are chronically supported with the HeartMate 3 LVAD. The study will compare two different antithrombotic regimens: VKA with aspirin versus VKA without aspirin.\n\nEnd points:\n\nPrimary end point:\n\n* Composite of Survival free of any major hemocompatibility related adverse event at 1-year post randomization.\n\n  1. Major Hemocompatibility Related Adverse Event: Stroke, Pump Thrombosis (suspected or confirmed), major non surgical Bleeding (moderate or severe) (including intracranial bleeds that do not meet the stroke definition), Arterial Peripheral Thromboembolism\n\n     Secondary end point:\n* Non-surgical Major Hemorrhagic Events\n* Non-surgical Major Thrombotic Events\n* Survival\n* Stroke Rates\n* Pump Thrombosis Rates\n* Bleeding Rates, including:\n\n  * Non-surgical Bleeding\n  * Moderate Bleeding\n  * Severe Bleeding\n  * Fatal Bleeding\n  * GI Bleeding Descriptive endpoints\n* Hemocompatibility score:\n\na tiered hierarchal score that weighs each hemocompatibility related adverse event by its escalating clinical relevance⁸\n\n* Rehospitalizations\n* Economic Cost Implications\n* Subgroup analysis (patients with increased bleeding\u002Fthrombotic risk (i.e prior HRAE events)\n\nNumber of Subjects Required for Inclusion in Clinical Investigation:\n\nBased on ARIES results, 58 patients will need to be enrolled in each arm (116 total) to achieve 80% power to prove that the non-aspirin group is non-inferior to the aspirin group using a non-inferiority margin of 15% with the Farrington-Manning risk difference approach to non-inferiority at a one-sided alpha = 0.05. To account for an expected 10% dropout rate, up to 128 patients will be randomized in the trial.",[19,20],"Bleeding","Clot Blood",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},128,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Aspirin","81-100 mg, oral",[35],"Warfarin and Aspirin",[37],"ASPIRIN® tablets",{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":43},"Warfarin","Warfarin dose will be adjusted per patient for a goal INR 2-3. The individualized daily dose could range anywhere from 0.5-2 mg to 5-7 mg. Oral.",[35,42],"Warfarin without Aspirin",[44,45],"Vitamin K antagonist","COUMADIN",[47],{"measure":48,"description":49,"timeFrame":50},"Number of survival free patients of any major hemocompatibility related adverse events.","A Major Hemocompatibility Related Adverse Event is defined as: Stroke, Pump Thrombosis (suspected or confirmed), major non-surgical Bleeding (moderate or severe) (including intracranial bleeds that do not meet the stroke definition), Arterial Peripheral Thromboembolism. The events will be recorded and tallied per patient.","1 year post implant",[52,56,59,62,65,68],{"measure":53,"description":54,"timeFrame":55},"Number of Non-surgical Major Hemorrhagic Events","The following types of events will be recorded and tallied. MODERATE or severe bleeding as defined in the protocol. SEVERE or overt bleeding plus hemoglobin drop of 3 to \\\u003C 5 g\u002FdL (provided hemoglobin drop is related to bleed).\n\nAny transfusion with overt bleeding. Cardiac tamponade. Bleeding requiring surgical intervention for control (excluding dental, nasal, skin, or hemorrhoid).\n\nHypotension attributable to bleeding.","1 year",{"measure":57,"description":58,"timeFrame":55},"Number of Non-surgical Major Thrombotic Events","The following types of events will be recorded and tallied:\n\nThe Device Thrombosis, Stroke, Arterial non-CNS thromboembolism.",{"measure":60,"description":61,"timeFrame":55},"Survival Rate","Patients who survive at 1 year post implant will be recorded and tallied.",{"measure":63,"description":64,"timeFrame":55},"Stroke Incidence","The following types of events will be recorded and tallied. Ischemic Stroke Hemorrhagic Stroke",{"measure":66,"description":67,"timeFrame":55},"Pump Thrombosis Incidence","pump thrombosis or suspected will be recorded and tallied.",{"measure":69,"description":70,"timeFrame":55},"Bleeding Incidence","Bleeding Rates, including Non-surgical Bleeding, Moderate Bleeding, Severe Bleeding, Fatal Bleeding, GI Bleeding will be recorded and tallied.","ALL","18 Years",false,{"inclusion":75,"exclusion":80,"raw_text":85},[76,77,78,79],"Participant will have HeartMate3 LVAD implanted \\> 3 months before enrollment.","\\>18 years old","Treated with aspirin and VKA","Participant must provide written informed consent prior to any clinical investigation-related procedure",[81,82,83,84],"Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)","Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome","Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results","Pregnant and on appropriate contraception","Inclusion Criteria:\n\n* Participant will have HeartMate3 LVAD implanted \\> 3 months before enrollment.\n* \\>18 years old\n* Treated with aspirin and VKA\n* Participant must provide written informed consent prior to any clinical investigation-related procedure\n\nExclusion Criteria:\n\n* Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)\n* Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results\n* Pregnant and on appropriate contraception",[87,88],"ADULT","OLDER_ADULT",[90,99,114],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"University of Chicago","Chicago","Illinois","60637","United States",{"lat":97,"lon":98},41.85003,-87.65005,{"facility":100,"status":8,"city":101,"state":101,"zip":102,"country":95,"contacts":103,"geoPoint":111},"Columbia Irving Medical Center","New York","10032",[104,109],{"name":105,"role":106,"phone":107,"email":108},"Nir Uriel, MD","CONTACT","212-305-7600","nu2126@cumc.columbia.edu",{"name":105,"role":110},"PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},40.71427,-74.00597,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":95,"geoPoint":119},"The University of Texas Health Science Center at Houston","Houston","Texas","77030",{"lat":120,"lon":121},29.76328,-95.36327,[123],{"name":105,"role":106,"phone":124,"email":108},"2123057600",[126],{"name":105,"affiliation":127,"role":110},"Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University",[],[],{"nct_id":4,"conditions":131,"biomarkers":133},[132],"Heart Failure",[],{"nct_id":4,"found":135,"summary":136,"prompt_version":146},true,{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is a randomized, controlled study, meaning participants will be randomly assigned to one of two treatment groups. It will compare taking warfarin with aspirin versus taking warfarin without aspirin.","completed","Aspirin and Bleeding\u002FClotting Events in HeartMate3 LVAD Patients","This study is looking at whether patients with advanced heart failure who have a HeartMate3 LVAD (a mechanical heart pump) can safely stop taking aspirin. Currently, these patients take both aspirin and warfarin (a blood thinner) to prevent clots. The study wants to see if removing aspirin from this treatment plan will reduce bleeding without increasing the risk of clots. You could be eligible if you are over 18, have had a HeartMate3 LVAD for more than 3 months, and are currently taking both aspirin and warfarin. The main goal is to see how many patients are free from major bleeding or clotting events one year after joining the study. This study plans to enroll 128 participants.","Participants will be followed for one year after they are randomly assigned to a treatment group to track major bleeding or clotting events.",117,"Not specified in the trial record.","Not stated in the trial record.",[32,39],"v2"]