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

ConditionsLeft Ventricular ThrombusAcute Myocardial Infarction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apixaban

    Drug

    5 mg tablet twice a daily with dose reduction according to label

  • Warfarin

    Drug

    2.5 mg tablet once daily, with individual dosing according to coagulation tests

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: ApixabanExperimental treatment 1 intervention
Group B: WarfarinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Karolinska Trial Alliance

Collaborator

Swedish Heart Lung Foundation

Collaborator

The Swedish Research Council

Collaborator

Stockholm County Council ALF/PPG

Collaborator

Source ClinicalTrials.gov
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