BleedingPhase 4NCT06655376
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
A Phase 4 study testing Aspirin and Warfarin in people with Bleeding and Clot Blood, run by Columbia University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Clot Blood
- What is being tested?
- Aspirin and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2024to 1 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
- Recruiting
Columbia Irving Medical Center
New York, New York, 10032
Nir Uriel, MD, 212-305-7600, nu2126@cumc.columbia.edu
Nir Uriel, MD
About this study
Official title: Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device
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.
Read the detailed description
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.
Hypothesis: 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.
Clinical 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.
End points:
Primary end point:
- Composite of Survival free of any major hemocompatibility related adverse event at 1-year post randomization.
- 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 Secondary end point:
- Non-surgical Major Hemorrhagic Events
- Non-surgical Major Thrombotic Events
- Survival
- Stroke Rates
- Pump Thrombosis Rates
- Bleeding Rates, including:
- Non-surgical Bleeding
- Moderate Bleeding
- Severe Bleeding
- Fatal Bleeding
- GI Bleeding Descriptive endpoints
- Hemocompatibility score: a tiered hierarchal score that weighs each hemocompatibility related adverse event by its escalating clinical relevance⁸
- Rehospitalizations
- Economic Cost Implications
- Subgroup analysis (patients with increased bleeding/thrombotic risk (i.e prior HRAE events)
Number of Subjects Required for Inclusion in Clinical Investigation:
Based 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.
- Conditions
- Bleeding, Clot Blood
- Medical subject headings
- Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called ASPIRIN® tablets
81-100 mg, oral
WarfarinDrug
Also called Vitamin K antagonist, COUMADIN
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.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin without Aspirin | Experimental | Participants will only take Warfarin. Receives: Drug: Warfarin |
| Warfarin and Aspirin | Active comparator | This is the control arm. Participants will take Warfarin and aspirin, which is the standard of care. Receives: Drug: Aspirin; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post implant
Secondary outcomes (6)
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.
Measured: 1 year
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.
Measured: 1 year
Survival Rate
Patients who survive at 1 year post implant will be recorded and tallied.
Measured: 1 year
Stroke Incidence
The following types of events will be recorded and tallied. Ischemic Stroke Hemorrhagic Stroke
Measured: 1 year
Pump Thrombosis Incidence
pump thrombosis or suspected will be recorded and tallied.
Measured: 1 year
Bleeding Incidence
Bleeding Rates, including Non-surgical Bleeding, Moderate Bleeding, Severe Bleeding, Fatal Bleeding, GI Bleeding will be recorded and tallied.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start2 Oct 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Nir Uriel, Columbia University
- Investigators
- Nir Uriel, MD, Principal investigator, Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655376
- Sponsor's protocol ID
- AAAV3358
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT06655376
- Acronym / sponsor ID
- AAAV3358
- Conditions
- Bleeding, Clot Blood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, The University of Texas Health Science Center, Houston
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Hypothesis: 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.
Clinical 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.
End points:
Primary end point:
- Composite of Survival free of any major hemocompatibility related adverse event at 1-year post randomization.
- 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 Secondary end point:
- Non-surgical Major Hemorrhagic Events
- Non-surgical Major Thrombotic Events
- Survival
- Stroke Rates
- Pump Thrombosis Rates
- Bleeding Rates, including:
- Non-surgical Bleeding
- Moderate Bleeding
- Severe Bleeding
- Fatal Bleeding
- GI Bleeding Descriptive endpoints
- Hemocompatibility score: a tiered hierarchal score that weighs each hemocompatibility related adverse event by its escalating clinical relevance⁸
- Rehospitalizations
- Economic Cost Implications
- Subgroup analysis (patients with increased bleeding/thrombotic risk (i.e prior HRAE events)
Number of Subjects Required for Inclusion in Clinical Investigation:
Based 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin without Aspirin | Experimental | Drug: WarfarinParticipants will only take Warfarin. |
| Warfarin and Aspirin | Active comparator | Drug: Aspirin, Drug: WarfarinThis is the control arm. Participants will take Warfarin and aspirin, which is the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: ASPIRIN® tablets81-100 mg, oral | Drug | Warfarin and Aspirin |
| WarfarinAlso: Vitamin K antagonist, COUMADINWarfarin 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. | Drug | Warfarin and Aspirin, Warfarin without Aspirin |
Primary outcome
Number of survival free patients of any major hemocompatibility related adverse events.
Time frame: 1 year post implant
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.
6 secondary outcomes
Number of Non-surgical Major Hemorrhagic Events
Time frame: 1 year
Number of Non-surgical Major Thrombotic Events
Time frame: 1 year
Survival Rate
Time frame: 1 year
Stroke Incidence
Time frame: 1 year
Pump Thrombosis Incidence
Time frame: 1 year
Bleeding Incidence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nir Uriel, MD principal investigator
Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Warfarin in people with Bleeding and Clot Blood, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nir Uriel, MD (2123057600, nu2126@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of survival free patients of any major hemocompatibility related adverse events. (time frame: 1 year post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.