Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
The optimal anticoagulant for the treatment of left ventricular (LV) thrombus following acute myocardial infarction (AMI) is unclear. The aim of this multicenter randomized study is to evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with LV thrombus after AMI.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of signing the informed consent
LV thrombus confirmed on TTE* day 1-28 after the AMI
Signed informed consent
Criteria applicable only for female subjects: Women of childbearing potential must provide a negative pregnancy test not be breastfeeding and be willing and able to use highly effective contraception. Women of non-childbearing potential must be 1 year post-menopausal.
Disqualifiers
Ongoing* treatment with anticoagulant therapy due to Mechanical heart valve prosthesis Atrial fibrillation with or without significant mitral valve stenosis Venous thromboembolism requiring anticoagulant therapy Thrombophilia requiring anticoagulant therapy Preexisting LV thrombus already treated with anticoagulant therapy Other reasons for anticoagulant therapy
High bleeding risk Active non-trivial bleeding Known chronic bleeding disorder Severe anemia defined as hemoglobin < 80g/L Thrombocytopenia defined as platelet count < 80 x 10^9
Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or known hepatic insufficiency classified as Child-Pugh C or D at randomization
Known allergy, intolerance or hypersensitivity to either of the study interventions
Trial design
Treatments tested in this trial
- Apixaban
- Warfarin
Treatment groups
212 Participants
are divided into 2 treatment groupsSponsors and collaborators
Karolinska Institutet
Lead sponsor
Karolinska Trial Alliance
Collaborator
Swedish Heart Lung Foundation
Collaborator
The Swedish Research Council
Collaborator
Stockholm County Council ALF/PPG
Collaborator
Source ClinicalTrials.gov