Status:
RECRUITING
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska Trial Alliance
Swedish Heart Lung Foundation
Conditions:
Left Ventricular Thrombus
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06515730
Start Date
April 8 2025
End Date
July 1 2028
Last Update
July 1 2025
Active Locations (16)
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1
Falu lasarett
Falun, Sweden
2
Sahlgrenska University hospital, Mölndal
Gothenburg, Sweden
3
Sahlgrenska University hospital, Östra
Gothenburg, Sweden
4
Sahlgrenska University hospital
Gothenburg, Sweden