Clinical trial NCT06515730: Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Official title: RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Left Ventricular Thrombus
Acute Myocardial Infarction
Keywords: Apixaban
warfarin
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, multicenter, open-label, blinded outcome assessment, parallel arm, active comparator, randomized study
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number and proportion of participants with thrombus resolution at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Clinically relevant bleeding at 3 and 12 months
timeFrame: 3 and 12 months
measure: Severe bleeding at 3 and 12 months
timeFrame: 3 and 12 months
measure: Separate bleeding outcomes at 3 and 12 months
timeFrame: 3 and 12 months
measure: Major adverse cardiovascular outcomes (MACE) at 3 and 12 months
timeFrame: 3 and 12 months
measure: Stroke or systemic embolism at 3 and 12 months
timeFrame: 3 and 12 months
measure: LV thrombus status at 12 months
timeFrame: 12 months
measure: Net adverse clinical outcomes
timeFrame: 3 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine Solna, Karolinska Institutet
name: Moa Simonsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: