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Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy (PREVENT II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836652
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: HeartMate II (HMII) Drug: Warfarin Drug: acetylsalicylic acid (ASA) therapy Phase 4

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:

  1. Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day)
  2. 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 TE events.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : July 18, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant
 Device: HeartMate II (HMII)
Left Ventricular Assist Device

Drug: Warfarin
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Other Name: Coumadin
Active Comparator: Control Arm
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
 Device: HeartMate II (HMII)
Left Ventricular Assist Device

Drug: Warfarin
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Other Name: Coumadin

Drug: acetylsalicylic acid (ASA) therapy
(81mg/day)
Other Name: Aspirin


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of non-surgical bleeding [ Time Frame: 6 months post initial implantation ]
  2. Composite incidence of pump thrombosis and thromboembolic (TE) stroke [ Time Frame: 6 months post initial implantation ]

Secondary Outcome Measures :
  1. Overall bleeding [ Time Frame: 12 months post-implant ]
  2. GI bleeding [ Time Frame: 12 months post-implant ]
  3. Suspected and confirmed pump thrombosis [ Time Frame: 12 months post-implant ]
  4. Stroke (ischemic and hemorrhagic) [ Time Frame: 12 months post-implant ]
  5. Hemolysis (major and minor) [ Time Frame: 12 months post-implant ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Abiomed 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836652


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Poornima Sood, M.D. Abbott Medical Devices
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02836652    
Other Study ID Numbers: SJM-CIP-10134
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Abbott Medical Devices:
HeartMate II (HMII)
Left Ventricular Assist Device (LVAD)
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants