Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

January 31, 2029

Conditions
Advanced Heart FailureLeft Ventricular Assist DevicesAnticoagulation TreatmentBleeding ComplicationsThrombotic Complications
Interventions
DRUG

Warfarin (low-intensity anticoagulation)

"Low-intensity INR group (Experimental):~Participants will receive anticoagulation therapy with warfarin, aiming for a reduced INR range of 1.5-2.0, which is lower than the current standard recommendation. Warfarin dosing will be regularly adjusted based on INR monitoring throughout the 6-month study period."

DRUG

Warfarin (standard anticoagulation)

"Standard INR group (Active Comparator):~Participants will receive anticoagulation therapy with warfarin, maintaining an INR within the standard therapeutic range of 2.0-3.0. Warfarin dosing adjustments will be made regularly according to standard clinical practice and INR monitoring throughout the 6-month study period."

Trial Locations (1)

05505

Asan Medical Center, University of Ulsan College of Medicine, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER