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

Heart Failure Clinical Trial

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

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02836652
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase Phase 4
Start date November 2016
Completion date July 18, 2019
View Details
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