RecruitingPhase 4NCT06515730

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

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


Sponsor

Karolinska Institutet

Enrollment

212 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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


Locations(16)

Falu lasarett

Falun, Sweden

Sahlgrenska University hospital, Mölndal

Gothenburg, Sweden

Sahlgrenska University hospital, Östra

Gothenburg, Sweden

Sahlgrenska University hospital

Gothenburg, Sweden

Linköping University hospital

Linköping, Sweden

Skånes Universitetssjukhus Lund

Lund, Sweden

Skånes University hospital, Malmö

Malmo, Sweden

Vrinnevi hospital

Nörrköping, Sweden

Örebro University hospital

Örebro, Sweden

Karolinska Insitutet

Stockholm, Sweden

Danderyds hospital

Stockholm, Sweden

Karolinska Univerity Hospital

Stockholm, Sweden

Sankt Görans Hospital

Stockholm, Sweden

Södersjukhuset

Stockholm, Sweden

Uppsala Akademiska hospital

Uppsala, Sweden

Västmanlands hospital, Västerås

Västerås, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06515730