Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
This 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin
Drug81-100 mg, oral
Warfarin
DrugWarfarin 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Warfarin without AspirinExperimental treatment 1 intervention
Group B: Warfarin and AspirinActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year post implantSecondary outcomes
1
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 \< 5 g/dL (provided hemoglobin drop is related to bleed). Any transfusion with overt bleeding. Cardiac tamponade. Bleeding requiring surgical intervention for control (excluding dental, nasal, skin, or hemorrhoid). Hypotension attributable to bleeding.
Time frame
1 year2
Number of Non-surgical Major Thrombotic Events
The following types of events will be recorded and tallied: The Device Thrombosis, Stroke, Arterial non-CNS thromboembolism.
Time frame
1 year3
Survival Rate
Patients who survive at 1 year post implant will be recorded and tallied.
Time frame
1 year4
Stroke Incidence
The following types of events will be recorded and tallied. Ischemic Stroke Hemorrhagic Stroke
Time frame
1 yearOther outcomes
1
Hemocompatibility Score
A tiered hierarchal score that weighs each hemocompatibility related adverse event by its escalating clinical relevance will be recorded and scored. Mild events (e.g., ≤2 nonsurgical bleeding episodes) contribute a single point to the HCS, whereas serious events (e.g., disabling stroke) contribute a higher grade to the HCS (e.g., disabling stroke contributes 4 points). The score will be calculated for each patient by summing up all the points associated with each HRAE experienced by the patient for the duration of available follow-up. The minimum score is 0, and there is no maximum score. A higher score indicates more series thrombotic/bleeding related complications.
Time frame
1 year2
Number of Rehospitalizations
number of all hospitalizations at 1 year, including number of HF related hospitalizations, will be tallied.
Time frame
1 year3
Averaged Days of hospitalization
This is to measure economic cost. Health resource utilization will be assessed by comparing days hospitalized (categorized by intensive care vs general ward) between groups.
Time frame
1 year4
Number of patients with increased bleeding/thrombotic risk
Patients with increased events when compared to prior HRAE events will be assessed and tallied.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Weill Medical College of Cornell University
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
Source ClinicalTrials.gov