Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Recruiting now · Phase 4
Conditions studied: Left Ventricular Thrombus, Acute Myocardial Infarction
In brief
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.
Key facts
- Study ID
- NCT06515730
- Run by
- Karolinska Institutet
- People needed
- 212
- Starts
- 2025-04-08
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2025-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 drug abuse
- Any other condition, as judged by the investigator, that would make the participant unsafe or unsuitable for the study or life expectancy < 6 months
Where it is running
- Skånes Universitetssjukhus Lund — Lund, Sweden (enrolling)
- Karolinska Univerity Hospital — Stockholm, Sweden (enrolling)
- Karolinska Insitutet — Stockholm, Sweden (enrolling)
- Sahlgrenska University hospital — Gothenburg, Sweden
- Linköping University hospital — Linköping, Sweden
- Skånes University hospital, Malmö — Malmö, Sweden
- Vrinnevi hospital — Nörrköping, Sweden
- Örebro University hospital — Örebro, Sweden
- Danderyds hospital — Stockholm, Sweden
- Sankt Görans Hospital — Stockholm, Sweden
- Södersjukhuset — Stockholm, Sweden
- Uppsala Akademiska hospital — Uppsala, Sweden
- Falu lasarett — Falun, Sweden
- Västmanlands hospital, Västerås — Västerås, Sweden
- Sahlgrenska University hospital, Mölndal — Gothenburg, Sweden
- Sahlgrenska University hospital, Östra — Gothenburg, Sweden
Full record on ClinicalTrials.gov
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