Heart FailurePhase 4PREVENT IINCT02836652
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
A Phase 4 study testing HeartMate II (HMII), Warfarin and acetylsalicylic acid (ASA) therapy in people with Heart Failure, run by Abbott Medical Devices at 35 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartMate II (HMII), Warfarin and acetylsalicylic acid (ASA) therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Nov 2016to 18 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States33 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Seton Medical Center
Austin, Texas, 78705
University of Alabama Hospital at Birmingham (UAB)
Birmingham, Alabama, 35249
Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Christ Hospital
Cincinnati, Ohio, 45219
Palmetto Health Richland
Columbia, South Carolina, 29203
Ohio State University
Columbus, Ohio, 43210
Baylor University Hospital
Dallas, Texas, 75246
Henry Ford Hospital
Detroit, Michigan, 48202
Shands at the University of Florida
Gainesville, Florida, 32610
Memorial Hermann
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46240
Kansas University Medical Center
Kansas City, Kansas, 66160
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Baptist Memorial Hospital
Memphis, Tennessee, 38120
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York Presbyterian Hospital/Columbia University
New York, New York, 10032
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Florida Hospital
Orlando, Florida, 32803
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Providence St. Vincent
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
Sharp Memorial Hospital
San Diego, California, 92123
University of California at San Francisco
San Francisco, California, 94131
Stony Brook University Medical Center
Stony Brook, New York, 11790
Montefiore Medical Center
The Bronx, New York, 10467
Westchester Medical Center
Valhalla, New York, 10595
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada2 sites
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, Quebec, G1V 4G5
About this study
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.
Read the detailed description
This is a post-market clinical study of HM II patient management practices to be conducted in the United States.
Subjects will be randomized in a 1:1 fashion to the following research drug groups:
- Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day)
- Control Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + ASA Therapy (81mg/day)
The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.
- Conditions
- Heart Failure
- Being tested
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Keywords
- HeartMate II (HMII), Left Ventricular Assist Device (LVAD)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate II (HMII)Device
Left Ventricular Assist Device
WarfarinDrug
Also called Coumadin
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
acetylsalicylic acid (ASA) therapyDrug
Also called Aspirin
(81mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant Receives: Device: HeartMate II (HMII); Drug: Warfarin |
| Control Arm | Active comparator | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant Receives: Device: HeartMate II (HMII); Drug: Warfarin; Drug: acetylsalicylic acid (ASA) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months post initial implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startNov 2016
- Primary completion21 Feb 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Crandall, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836652
- Sponsor's protocol ID
- SJM-CIP-10134
- Acronym
- PREVENT II
- Status last verified
- Jun 2022
- First submitted
- 12 Jul 2016
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT02836652
- Acronym / sponsor ID
- PREVENT II / SJM-CIP-10134
- Conditions
- Heart Failure
- Keywords
- HeartMate II (HMII), Left Ventricular Assist Device (LVAD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Posted 29 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a post-market clinical study of HM II patient management practices to be conducted in the United States.
Subjects will be randomized in a 1:1 fashion to the following research drug groups:
- Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day)
- Control Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + ASA Therapy (81mg/day)
The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: HeartMate II (HMII), Drug: WarfarinWarfarin (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 comparator | Device: HeartMate II (HMII), Drug: Warfarin, Drug: acetylsalicylic acid (ASA) therapyWarfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| HeartMate II (HMII)Left Ventricular Assist Device | Device | Control Arm, Treatment Arm |
| WarfarinAlso: Coumadin(INR Target 2.0-2.5, median 2.25, per standard of patient care) | Drug | Control Arm, Treatment Arm |
| acetylsalicylic acid (ASA) therapyAlso: Aspirin(81mg/day) | Drug | Control Arm |
Primary outcome
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant
Time frame: 6 months post initial implantation
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).
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant
Time frame: 6 months post initial implantation
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Daniel Crandall study director
Abbott
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HeartMate II (HMII), Warfarin and acetylsalicylic acid (ASA) therapy in people with Heart Failure, run by Abbott Medical Devices at 35 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant (time frame: 6 months post initial implantation). The study lists 2 primary outcomes in all. 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 Jun 2022.