RandomizEd compariSOn of apixaban versus warfarin in patients with Left VEntricular thrombus after Acute Myocardial Infarction (RESOLVE-AMI).

Phase 4

Recruiting

• Conditions: Left ventricular thrombosis.; Acute mycocardial infarction (AMI)

• Registration Number: 2024-514416-28-00
• Lead Sponsor: Karolinska Institutet

Brief Summary

The primary objective of this study is to compare the effect of apixaban versus warfarin with respect to thrombus resolution in patients with left ventricular thrombus after acute myocardial infarction (AMI).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Study Start: 2025-04-08
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Primary Completion: 2028-04-08
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 212

Inclusion Criteria

Participants must be ≥ 18 years at the time of signing the informed consent.

Left ventricular thrombus confirmed on transthoracic echocardiogram (TTE) or when inconclusive documented on cardiac magnet resonance imaging (MRI) or computed tomography (CT) on day 1-28 after the acute myocardial infarction.

The subject has given their written consent to participate in the trial which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and study protocol.

Criteria applicable only for female subjects: A) Women of childbearing potential must provide a negative pregnancy test at inclusion, not be breastfeeding and be willing and able to use highly effective contraception during the treatment and up to 3 months after the last dose of study drug; B) Women of non-childbearing potential must be 1 year post-menopausal.

Exclusion Criteria

Ongoing treatment with anticoagulant therapy due to: A) Mechanical heart valve prosthesis (not including transcatheter aortic valve replacement); B) Atrial fibrillation with or without significant mitral valve stenosis; C) Venous thromboembolism requiring anticoagulant therapy; D) Thrombophilia requiring anticoagulant therapy; E) Preexisting left ventricular thrombus already on anticoagulant therapy; F) Other reasons for anticoagulant therapy.

High bleeding risk: A) Active non-trivial bleeding; B) Known chronic bleeding disorder; C) Severe anemia defined as hemoglobin < 80g/L; D) Thrombocytopenia defined as thrombocytes <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 (active substance or excipients).

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 that may interfere with participants safety and or compliance as judged at the discretion of the investigator.

Any other condition, as judged by the investigator, that would make the participant unsafe or unsuitable for the study (anticipated non-compliance or vulnerability) or very short life expectancy < 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.		Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
Clinically relevant bleeding - BARC (Bleeding Academy Research Consortium) 2, 3 or 5 bleeding.		Clinically relevant bleeding - BARC (Bleeding Academy Research Consortium) 2, 3 or 5 bleeding.
Major bleeding BARC 3 or 5 bleeding.		Major bleeding BARC 3 or 5 bleeding.
Individual bleeding endpoints (Fatal bleeding, intracranial hemorrhage, GI bleeding, urogenital bleeding and bleeding of other sources).		Individual bleeding endpoints (Fatal bleeding, intracranial hemorrhage, GI bleeding, urogenital bleeding and bleeding of other sources).
Major adverse cardiovascular events (MACE). Composite of non-fatal myocardial infarction, non-fatal ischemic stroke and cardiovascular death.		Major adverse cardiovascular events (MACE). Composite of non-fatal myocardial infarction, non-fatal ischemic stroke and cardiovascular death.
Net clinical benefit: Composite of MACE and BARC 2, 3 or 5 bleeding.		Net clinical benefit: Composite of MACE and BARC 2, 3 or 5 bleeding.
Ischemic stroke and systemic embolism.		Ischemic stroke and systemic embolism.
Recurrence of LV thrombus at 12 months.		Recurrence of LV thrombus at 12 months.

Trial Locations

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; 🇸🇪 Malmö, Sweden

Vrinnevi hospital; 🇸🇪 Nörrköping, Sweden

Karolinska Insitutet; 🇸🇪 Stockholm, Sweden

Danderyds hospital; 🇸🇪 Stockholm, Sweden

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