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Recruiting Phase 4 NCT06515730

NCT06515730 Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction

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Clinical Trial Summary
NCT ID NCT06515730
Status Recruiting
Phase Phase 4
Sponsor Karolinska Institutet
Condition Left Ventricular Thrombus
Study Type INTERVENTIONAL
Enrollment 212 participants
Start Date 2025-04-08
Primary Completion 2028-04-08

Trial Parameters

Condition Left Ventricular Thrombus
Sponsor Karolinska Institutet
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 212
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-08
Completion 2028-04-08
Interventions
ApixabanWarfarin

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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 efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with LV thrombus after AMI.

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 1

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