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NCT Number: NCT06515730

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Falu lasarett, Falun, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

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

Other names: Eliquis

Warfarin

Drug

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

Other names: Waran

Primary outcomes

  1. Number and proportion of participants with thrombus resolution at 3 months

    Time frame: 3 months

    Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE*) at 3 months

Secondary outcomes

  1. Clinically relevant bleeding at 3 and 12 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.

  2. Severe bleeding at 3 and 12 months

    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.

  3. Separate bleeding outcomes at 3 and 12 months

    Time frame: 3 and 12 months

    Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding

  4. Major adverse cardiovascular outcomes (MACE) at 3 and 12 months

    Time frame: 3 and 12 months

    MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death

  5. Stroke or systemic embolism at 3 and 12 months

    Time frame: 3 and 12 months

    Composite of ischemic stroke or systemic embolism

  6. LV thrombus status at 12 months

    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

  7. Net adverse clinical outcomes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Olofsson

CONTACT

[email protected]

+46707780897

Stina Smetana

CONTACT

[email protected]

+46725841182

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska Trial Alliance
  • Stockholm County Council ALF/PPG
  • Swedish Heart Lung Foundation
  • The Swedish Research Council

Registry information

Official study title

RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)

Acronym: RESOLVE-AMI

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2024
Registry last updated
Jul 1, 2025

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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