APIXABAN for Left ventricular thrombosis | Acute myocardial infarction

Inclusion criteria

• {"criterion_text":"- Participants must be ≥ 18 years at the time of signing the informed consent."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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

• {"criterion_text":"- Ongoing treatment with anticoagulant therapy due to: A) Mechanical heart valve prosthesis (not including transcatheter aortic valve replacement); B)\tAtrial 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."}
• {"criterion_text":"- High bleeding risk: A)\tActive 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Known allergy, intolerance or hypersensitivity to either of the study interventions (active substance or excipients)."}
• {"criterion_text":"- Any contraindication for the use of an anticoagulant or listed in the local labelling for Apixaban or warfarin."}
• {"criterion_text":"- Participation in other study investigating effects and safety of anticoagulant treatment."}
• {"criterion_text":"- Known current alcohol or drug abuse that may interfere with participants safety and or compliance as judged at the discretion of the investigator."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Evaluated by transthoracic echocardiogram (preferably contrast-enhanced) at 3 months; if TTE inconclusive, cardiac MRI or cardiac CT is recommended to evaluate thrombus resolution."}

Secondary endpoints

• {"endpoint_text":"- Clinically relevant bleeding - BARC (Bleeding Academy Research Consortium) 2, 3 or 5 bleeding.","definition_or_measurement_approach":"Bleeding categorized using BARC definitions 2, 3 or 5."}
• {"endpoint_text":"- Major bleeding BARC 3 or 5 bleeding.","definition_or_measurement_approach":"Major bleeding categorized as BARC 3 or 5."}
• {"endpoint_text":"- Individual bleeding endpoints (Fatal bleeding, intracranial hemorrhage, GI bleeding, urogenital bleeding and bleeding of other sources).","definition_or_measurement_approach":"Incidence of specified individual bleeding events (fatal bleeding, intracranial, GI, urogenital, other)."}
• {"endpoint_text":"- Major adverse cardiovascular events (MACE). Composite of non-fatal myocardial infarction, non-fatal ischemic stroke and cardiovascular death.","definition_or_measurement_approach":"Composite MACE defined as non-fatal MI, non-fatal ischemic stroke and cardiovascular death."}
• {"endpoint_text":"- Net clinical benefit: Composite of MACE and BARC 2, 3 or 5 bleeding.","definition_or_measurement_approach":"Composite endpoint combining MACE and clinically relevant bleeding (BARC 2,3,5)."}
• {"endpoint_text":"- Ischemic stroke and systemic embolism.","definition_or_measurement_approach":"Incidence of ischemic stroke and systemic embolism events."}
• {"endpoint_text":"- Recurrence of LV thrombus at 12 months.","definition_or_measurement_approach":"Assessment of left ventricular thrombus recurrence at 12 months after index event."}

Sweden

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

387

Number Of Sites

18

Number Of Participants

212

Denmark

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

5

Number Of Sites

2

Number Of Participants

75

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Hjärt-Lungfonden","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"ALF medel (SLL)","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"Vetenskapsrådet (VR)","duties_or_roles":"Monetary support / funding","organisation_type":""}