Apixaban
Drug5 mg tablet twice a daily with dose reduction according to label
Other names: Eliquis
NCT Number: NCT06515730
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Falu lasarett, Falun, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 mg tablet twice a daily with dose reduction according to label
Other names: Eliquis
2.5 mg tablet once daily, with individual dosing according to coagulation tests
Other names: Waran
Time frame: 3 months
Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE*) at 3 months
Time frame: 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 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 defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding
Time frame: 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
Composite of ischemic stroke or systemic embolism
Time frame: 12 months
Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Eva Olofsson
CONTACT
Stina Smetana
CONTACT
Karolinska Institutet
Other
RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
Acronym: RESOLVE-AMI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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