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

Phase 4

Not yet recruiting

• Conditions: Left Ventricular Thrombus; Acute Myocardial Infarction
• Interventions: Drug: Apixaban; Drug: Warfarin

• Registration Number: NCT06515730
• Lead Sponsor: Karolinska Institutet

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.

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
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Study Start: 2024-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apixaban	Apixaban	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.
Warfarin	Warfarin	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.

Primary Outcome Measures

Name	Time	Method
Number and proportion of participants with thrombus resolution at 3 months	3 months	Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE\*) at 3 months

Secondary Outcome Measures

Name	Time	Method
Clinically relevant bleeding at 3 and 12 months	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.
Severe bleeding at 3 and 12 months	3 and 12 months	Severe bleeding defined as BARC 3 or 5. For definition of the BARC bleeding scale please see Outcome 2 above.
Separate bleeding outcomes at 3 and 12 months	3 and 12 months	Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding
Major adverse cardiovascular outcomes (MACE) at 3 and 12 months	3 and 12 months	MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death
Stroke or systemic embolism at 3 and 12 months	3 and 12 months	Composite of ischemic stroke or systemic embolism
LV thrombus status at 12 months	12 months	Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months
Net adverse clinical outcomes	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.