Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
628 participants
INTERVENTIONAL
2020-07-14
2023-08-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients with Assist Device
NCT06655376
Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI
NCT02640794
A Phase III Study of Apixaban in Patients With Atrial Fibrillation
NCT00496769
Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)
NCT02735902
Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial
NCT01559298
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo Arm
LVAD Patients on the placebo arm will be given placebo medication
LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Placebo oral tablet
Subjects will be randomized to either Placebo or Aspirin post implant
Active Arm
LVAD Patients on the active arm will be given 100mg Aspirin
LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Aspirin 100mg
Subjects will be randomized to either Placebo or Aspirin post implant.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Aspirin 100mg
Subjects will be randomized to either Placebo or Aspirin post implant.
Placebo oral tablet
Subjects will be randomized to either Placebo or Aspirin post implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject will receive the HeartMate 3 as their first durable VAD.
3. Subject must provide written informed consent prior to any clinical investigation related procedure.
4. In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.
Exclusion Criteria
2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
3. Patients who are nil per os (NPO) post-implant through day 7.
4. Subjects with a known allergy to acetylsalicylic acid (aspirin).
5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
6. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baptist Health Medical Center
Little Rock, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Miami Transplant Institute - Jackson Memorial
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center - Moses Division
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor University Hospital
Dallas, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
St. Vincent's Hospital, Sydney
Darlinghurst, New, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
AKH - Wien
Vienna, , Austria
University of Alberta Hospital
Edmonton, , Canada
IKEM Prague
Prague, Central Bohemia, Czechia
Hopital Haut Leveque
Pessac, , France
CHU Rangueil Toulouse
Toulouse, , France
Ospedale San Raffaele
Milan, , Italy
National Research Center for Cardiac Surgery
Astana, , Kazakhstan
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mehra MR, Netuka I, Uriel N, Katz JN, Pagani FD, Jorde UP, Gustafsson F, Connors JM, Ivak P, Cowger J, Ransom J, Bansal A, Takeda K, Agarwal R, Byku M, Givertz MM, Bitar A, Hall S, Zimpfer D, Vega JD, Kanwar MK, Saeed O, Goldstein DJ, Cogswell R, Sheikh FH, Danter M, Pya Y, Phancao A, Henderson J, Crandall DL, Sundareswaran K, Soltesz E, Estep JD; ARIES-HM3 Investigators. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2171-2181. doi: 10.1001/jama.2023.23204.
Gustafsson F, Uriel N, Netuka I, Katz JN, Pagani FD, Connors JM, Jorde UP, Zimpfer D, Pya Y, Conway J, Anyanwu A, Scandroglio AM, Sulemanjee N, Atluri P, Keebler M, Selzman CH, Alexis JD, Hayward C, Henderson J, Dirckx N, Gazzola C, Mehra MR; ARIES Investigators. Aspirin and Hemocompatibility After LVAD Implantation in Patients With Atherosclerotic Vascular Disease: A Secondary Analysis From the ARIES-HM3 Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):235-242. doi: 10.1001/jamacardio.2024.4849.
Mehra MR, Crandall DL, Gustafsson F, Jorde UP, Katz JN, Netuka I, Uriel N, Connors JM, Sood P, Heatley G, Pagani FD. Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial. Eur J Heart Fail. 2021 Jul;23(7):1226-1237. doi: 10.1002/ejhf.2275. Epub 2021 Jul 1.
Pagani FD, Netuka I, Jorde UP, Katz JN, Gustafsson F, Connors JM, Uriel N, Soltesz EG, Ivak P, Bansal A, Bitar A, Vega JD, Goldstein D, Danter M, Pya Y, Ravichandran A, Conway J, Adler ED, Chung ES, Grinstein J, Dirckx N, Iravani B, Mehra MR. Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy. JACC Heart Fail. 2025 Jul;13(7):102411. doi: 10.1016/j.jchf.2025.01.017. Epub 2025 Apr 9.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABT-CIP-10305
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.