Acute Myocardial Infarction, Left Ventricular Thrombus
Conditions
Keywords
Apixaban, warfarin
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.
Interventions
DRUGApixaban
5 mg tablet twice a daily with dose reduction according to label
DRUGWarfarin
2.5 mg tablet once daily, with individual dosing according to coagulation tests
Sponsors
Karolinska Trial Alliance
Swedish Heart Lung Foundation
The Swedish Research Council
Stockholm County Council ALF/PPG
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessment of the primary outcome of thrombus resolution will be performed through review of images by researchers who are blinded to the treatment assignment
Intervention model description
Investigator-initiated, multicenter, open-label, blinded outcome assessment, parallel arm, active comparator, randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and proportion of participants with thrombus resolution at 3 months | 3 months | Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE\*) at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe bleeding at 3 and 12 months | 3 and 12 months | Severe bleeding defined as BARC 3 or 5. For definition of the BARC bleeding scale please see Outcome 2 above. |
| Separate bleeding outcomes at 3 and 12 months | 3 and 12 months | Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding |
| Major adverse cardiovascular outcomes (MACE) at 3 and 12 months | 3 and 12 months | MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death |
| Clinically relevant bleeding at 3 and 12 months | 3 and 12 months | Clinical relevant bleeding defined as Bleeding Academy Research Consortium (BARC) 2, 3 or 5 bleeding. The BARC bleeding scale ranges from 0 to 5, where 0 is equal to no bleeding, with increasing severity from 1 through 5, where 5 represents fatal bleeding. Major bleeding is most often defined as BARC 3 and 5. BARC 4 bleeding is coronary artery bypass grafting (CABG) related bleeding. |
| LV thrombus status at 12 months | 12 months | Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months |
| Net adverse clinical outcomes | 3 and 12 months | Composite of MACE and. BARC 2, 3 or 5 bleeding. For definition of MACE and BARC bleeding scale please see Outcome 2 and 5 above. |
| Stroke or systemic embolism at 3 and 12 months | 3 and 12 months | Composite of ischemic stroke or systemic embolism |
Countries
Sweden
Contacts
Primary ContactEva Olofsson
Backup ContactStina Smetana
Outcome results
None listed