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

Abbott

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: Warfarin; Device: HeartMate II (HMII); Drug: acetylsalicylic acid (ASA) therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02836652

SJM-CIP-10134

Details and patient eligibility

About

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.

Full 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 thromboembolic events.

Enrollment: 72 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant

Treatment:

Device: HeartMate II (HMII)

Drug: Warfarin

Control Arm

Active Comparator group

Description:

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

Treatment:

Drug: acetylsalicylic acid (ASA) therapy

Device: HeartMate II (HMII)

Drug: Warfarin