Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)

Karolinska Institute

Status and phase: Enrolling; Phase 4

Conditions: Left Ventricular Thrombus; Acute Myocardial Infarction

Treatments: Drug: Warfarin; Drug: Apixaban

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06515730

RESOLVE-AMI

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

Apixaban

Experimental group

Description:

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.

Treatment:

Drug: Apixaban

Warfarin

Active Comparator group

Description:

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.

Treatment:

Drug: Warfarin