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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
212
Falu lasarett
Falun, Sweden
NOT_YET_RECRUITINGSahlgrenska University hospital, Mölndal
Gothenburg, Sweden
Number and proportion of participants with thrombus resolution at 3 months
Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE\*) at 3 months
Time frame: 3 months
Clinically relevant bleeding at 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.
Time frame: 3 and 12 months
Severe bleeding at 3 and 12 months
Severe bleeding defined as BARC 3 or 5. For definition of the BARC bleeding scale please see Outcome 2 above.
Time frame: 3 and 12 months
Separate bleeding outcomes at 3 and 12 months
Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding
Time frame: 3 and 12 months
Major adverse cardiovascular outcomes (MACE) at 3 and 12 months
MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death
Time frame: 3 and 12 months
Stroke or systemic embolism at 3 and 12 months
Composite of ischemic stroke or systemic embolism
Time frame: 3 and 12 months
LV thrombus status at 12 months
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Sahlgrenska University hospital, Östra
Gothenburg, Sweden
NOT_YET_RECRUITINGSahlgrenska University hospital
Gothenburg, Sweden
NOT_YET_RECRUITINGLinköping University hospital
Linköping, Sweden
NOT_YET_RECRUITINGSkånes Universitetssjukhus Lund
Lund, Sweden
RECRUITINGSkånes University hospital, Malmö
Malmo, Sweden
NOT_YET_RECRUITINGVrinnevi hospital
Nörrköping, Sweden
NOT_YET_RECRUITINGÖrebro University hospital
Örebro, Sweden
NOT_YET_RECRUITINGKarolinska Insitutet
Stockholm, Sweden
RECRUITING...and 6 more locations
Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months
Time frame: 12 months
Net adverse clinical outcomes
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.
Time frame: 3 and 12 months