Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute My… (NCT06515730) | Clinical Trial Compass
RecruitingPhase 4
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Sweden212 participantsStarted 2025-04-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban or warfarin.
* Participation in other study investigating effects and safety of anticoagulant treatment.
* Known current alcohol or…
What they're measuring
1
Number and proportion of participants with thrombus resolution at 3 months