Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction

Launched by KAROLINSKA INSTITUTET · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective two blood-thinning medications, apixaban and warfarin, are in treating a condition called left ventricular thrombus, which can occur after a heart attack. The goal is to find out which medication helps dissolve the blood clot in the heart better. The study will include adults aged 18 and older who have been diagnosed with this condition shortly after a heart attack and are willing to participate by providing informed consent.

If you or a family member are considering joining this trial, you should know that there are specific eligibility requirements. For example, participants must not be on certain other blood-thinning treatments or have any serious bleeding conditions. During the study, participants will be randomly assigned to receive either apixaban or warfarin and will be monitored for how well their condition improves. It’s important to note that this trial is not yet recruiting participants, so there may be a wait before enrollment begins.

Gender

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Eligibility criteria

• 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 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