drugset / Trial / NCT04865978

Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices

NCT04865978 ↗

Phase 2 Completed 30 enrolled Palak Shah Abbott Medical Devices · collab
RandomizedParallel-groupOpen-labelSupportive care

Summary

Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.

Timeline

Start
2021-12-14
Primary completion
2023-10-05
Completion
2023-11-07

Outcome

Missed primary endpoint

paper At 24 weeks, the primary composite outcome occurred in no patients receiving apixaban and in 2 patients (14%) receiving warfarin (P = 0.12) PMID 38795110 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule 5 mg —
Comparator Warfarin Small molecule — —

Indications