Comparing two anticoagulant treatment, Warfarin (Standard treatment) and Apixaban (A new treatment) in patients with a Mechanical Heart for bleeding and thrombosis complications.

Phase 4

Recruiting

• Conditions: Ventricular Assist Device (VAD); Bleeding; Thrombosis; Cardiovascular - Other cardiovascular diseases; Blood - Clotting disorders

• Registration Number: ACTRN12621000956808
• Lead Sponsor: St.Vincent Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-21
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients implanted with a Left Ventricular Assist Device (LVAD) and fulfilling the following (inclusion) criteria:
-Patients implanted with a ventricular assist device in the left ventricle
-Patients actively following up in the mechanical circulatory support clinic at St. Vincent’s Hospital, Sydney
-Bodyweight greater than 60 Kg
-Patients aged between 18 and 70 years
-Creatinine clearance greater than 25ml/min and creatinine level < 221mcmol/l
-Participant able to give an informed consent
-TTR in the preceding 4 weeks of 60% or more
-Reason for VAD implantation is either as a bridge to decision (BTD) or a bridge to transplant (BTT)

Exclusion Criteria

-Stroke following VAD implantation (if occurred more than 4 weeks after VAD implantation)
-Major bleeding (if occurred more than 4 weeks after VAD implantation)
-Requirement for treatment with aspirin at a dose greater than 100 mg per day
-Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel, prasugrel, ticagrelor)
-Women who are pregnant or breastfeeding
-Allergy to apixaban
-TTR <60% in the preceding 4 weeks
-Severe renal insufficiency (serum creatinine > 221mcmol/l or a calculated creatinine clearance < 25 mL/min)
-Alanine transaminase > 5x ULN or known cirrhotic liver disease
-Active alcohol or illicit drug use, or psychosocial reasons that make study participation impractical
-Patients with known Human Immunodeficiency Virus (HIV) infection
-Patients taking medications or other substances known to be potent inhibitors of the CYP3A4 enzyme (e.g. -azole antifungals (itraconazole and ketoconazole), macrolide antibiotics (clarithromycin and telithromycin), protease inhibitors (ritonavir, indinavir, nelfinavir, atazanavir, and saquinavir), and nefazadone)
-Patient taking medications or substances known to be potent inducers of the CAP3A4 enzyme (e.g. antituberculosis treatments (rifampicin))
-Allergy to any of component ingredients of Andexanet-alfa: tris, arginine, sucrose, hydrochloric acid, mannitol, and polysorbate 80 (if available).

Study & Design

• Study Type: Interventional
• Study Design: Not specified