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NCT02836652 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Abbott Medical Devices.

Completed
Registry status
Phase 4
Development phase
72
Enrollment target

NCT02836652: Completed Phase 4 study, sponsored by Abbott Medical Devices.

NCT02836652 is a Phase 4 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02836652, a Phase 4 study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
Phase 4
Development phase
72 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • DRUG Warfarin
  • DEVICE HeartMate II (HMII)
  • DRUG acetylsalicylic acid (ASA) therapy

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2016-11
Est. Completion 2019-07-18
Phase Phase 4
Abbott Medical Devices

261 total trials

What the finished NCT02836652 record still lists

NCT02836652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 3 interventions - of which Warfarin is the first listed.

NCT02836652 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02836652 about?

NCT02836652 is a clinical study titled "Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy". 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.

What is the current status of trial NCT02836652?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2016-11. Estimated completion is 2019-07-18.

What interventions are being tested in trial NCT02836652?

The interventions under investigation include: Warfarin (DRUG), HeartMate II (HMII) (DEVICE), acetylsalicylic acid (ASA) therapy (DRUG).

Who is sponsoring clinical trial NCT02836652?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02836652's enrollment target sits among peer trials

72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02836652, the US trial registry maintained by the National Library of Medicine. NCT02836652 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.