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

NCT06515730 | Recruiting Phase 4

• 1 other identifier: RESOLVE-AMI
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Left Ventricular Thrombus; Acute Myocardial Infarction

Keywords

Apixaban; warfarin

Outcome Measures

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

  3 months

Secondary Outcomes (7)

• Clinically relevant bleeding at 3 and 12 months

  3 and 12 months

• Severe bleeding at 3 and 12 months

  3 and 12 months

• Separate bleeding outcomes at 3 and 12 months

  3 and 12 months

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

  3 and 12 months

• Stroke or systemic embolism at 3 and 12 months

  3 and 12 months

Study Arms (2)

Apixaban

EXPERIMENTAL

Apixaban 5 mg twice a day, reduced to 2.5 mg twice a day for participants with any 2 of following criteria: age \> 80 years, serum creatinine \> 133 μmol/L or body weight \<60 kg. Participants with severe renal failure defined as creatinine clearance 15-29 ml/min/1.73 m2, should also receive the reduced dose of 2.5 mg twice a day.

Drug: Apixaban

Warfarin

ACTIVE COMPARATOR

Warfarin 2,5 mg once daily with individual dosing according to coagulation assays with an international normalized ratio (INR) goal of 2.0-3.0. Bridging with low-molecular-weight-heparin with a dose of dalteparin 200 units/kg but maximum 18 000 units or enoxaparin 150 units/kg, until therapeutic INR is recommended.

Drug: Warfarin

Interventions

Apixaban DRUG

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

Also known as: Eliquis

Apixaban

Warfarin DRUG

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

Also known as: Waran

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (16)

Falu lasarett

Falun, Sweden

NOT YET RECRUITING

Sahlgrenska University hospital, Mölndal

Gothenburg, Sweden

NOT YET RECRUITING

Sahlgrenska University hospital, Östra

Gothenburg, Sweden

NOT YET RECRUITING

Sahlgrenska University hospital

Gothenburg, Sweden

NOT YET RECRUITING

Linköping University hospital

Linköping, Sweden

NOT YET RECRUITING

Skånes Universitetssjukhus Lund

Lund, Sweden

RECRUITING

Skånes University hospital, Malmö

Malmo, Sweden

NOT YET RECRUITING

Vrinnevi hospital

Nörrköping, Sweden

NOT YET RECRUITING

Örebro University hospital

Örebro, Sweden

NOT YET RECRUITING

Karolinska Insitutet

Stockholm, 17177, Sweden

RECRUITING

Danderyds hospital

Stockholm, Sweden

NOT YET RECRUITING

Karolinska Univerity Hospital

Stockholm, Sweden

RECRUITING

Sankt Görans Hospital

Stockholm, Sweden

NOT YET RECRUITING

Södersjukhuset

Stockholm, Sweden

NOT YET RECRUITING

Uppsala Akademiska hospital

Uppsala, Sweden

NOT YET RECRUITING

Västmanlands hospital, Västerås

Västerås, Sweden

NOT YET RECRUITING

MeSH Terms

Interventions

apixaban; Warfarin; Vitamin B 6

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines

Study Officials

• Moa Simonsson, MD, PhD

  Department of Medicine Solna, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Olofsson

CONTACT

+46707780897; moa.simonsson@ki.se

Stina Smetana

CONTACT

+46725841182; stina.smetana@ki.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment of the primary outcome of thrombus resolution will be performed through review of images by researchers who are blinded to the treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Investigator-initiated, multicenter, open-label, blinded outcome assessment, parallel arm, active comparator, randomized study

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): April 8, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (16)