Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
PREVENT II
1 other identifier
interventional
72
2 countries
35
Brief Summary
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 heart-failure
Started Nov 2016
Typical duration for phase_4 heart-failure
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2019
CompletedResults Posted
Study results publicly available
October 29, 2020
CompletedJune 27, 2022
June 1, 2022
2.3 years
July 12, 2016
July 31, 2020
June 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant
Composite incidence of non-surgical bleeding at 6 months post initial implantation, including but not limited to gastrointestinal, genitourinary, epistaxis, subdural hematoma, and primary hemorrhagic stroke (not due to ischemic conversion, or due to the treatment of a hemolysis/suspected thrombosis event).
6 months post initial implantation
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant
Composite incidence of pump thrombosis and thromboembolic stroke at 6 months post initial implantation, including ischemic stroke, or hemorrhagic stroke due to an ischemic conversion/treatment of hemolysis/pump thrombosis event.
6 months post initial implantation
Other Outcomes (2)
Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant
12 months post-implant
Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices
12 months post-implant
Study Arms (2)
Treatment Arm
EXPERIMENTALWarfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant
Control Arm
ACTIVE COMPARATORWarfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant
Interventions
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Eligibility Criteria
You may qualify if:
- Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
- Subject is ≥ 50 years of age
- Subject is receiving the HM II as their first LVAD
- Subject or legally authorized representative (LAR) has signed an informed consent form (ICF).
You may not qualify if:
- Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Impella® devices
- Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
- Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed.
- Subjects in whom heart transplantation is expected in ≤ 6 months
- Subjects with a known ASA allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
University of Alabama Hospital at Birmingham (UAB)
Birmingham, Alabama, 35249, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
University of California at San Francisco
San Francisco, California, 94131, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Shands at the University of Florida
Gainesville, Florida, 32610, United States
Florida Hospital
Orlando, Florida, 32803, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
St. Vincent Hospital
Indianapolis, Indiana, 46240, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
New York Presbyterian Hospital/Columbia University
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11790, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio State University
Columbus, Ohio, 43210, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Providence St. Vincent
Portland, Oregon, 97225, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Seton Medical Center
Austin, Texas, 78705, United States
Baylor University Hospital
Dallas, Texas, 75246, United States
Memorial Hermann
Houston, Texas, 77030, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8, Canada
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, Quebec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1. The study did not complete enrollment due to competing enrollment in MOMENTUM 3. 2. Other adverse events were not collected in this study. 3. INR data are incomplete and hence, are not reported.
Results Point of Contact
- Title
- Poornima Sood
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Daniel Crandall
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2016
First Posted
July 19, 2016
Study Start
November 1, 2016
Primary Completion
February 21, 2019
Study Completion
July 18, 2019
Last Updated
June 27, 2022
Results First Posted
October 29, 2020
Record last verified: 2022-06