At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 72 enrolled
Drug / intervention
Warfarin +2 moredrug
Likely dose
acetylsalicylic acid (ASA) therapy 81mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
In Brief
A Phase 4 clinical trial evaluating HeartMate II (HMII), Warfarin, and 1 other intervention for Heart Failure. Completed, enrolled 72 participants across 35 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesCanada, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartNov 2016
Primary CompletionFeb 2019
Study CompletionJul 2019
TodayJul 2026
First PostedJul 19, 2016
Enrollment StartNov 1, 2016
Primary CompletionFeb 21, 2019
Study CompletionJul 18, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.0 years ago
Interventions
HeartMate II (HMII)device
Left Ventricular Assist Device
Warfarindrug
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
acetylsalicylic acid (ASA) therapydrug
(81mg/day)