Recruiting NCT06515730
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apixaban, Warfarin.
- Who it may be relevant to
- Registry conditions: Left Ventricular Thrombus, Acute Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
Overview
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.
Interventions
- Drug Apixaban
5 mg tablet twice a daily with dose reduction according to label - Drug Warfarin
2.5 mg tablet once daily, with individual dosing according to coagulation tests
Primary outcome measures
- Number and proportion of participants with thrombus resolution at 3 months [Time frame: 3 months]
Secondary outcome measures (7)
- Clinically relevant bleeding at 3 and 12 months [Time frame: 3 and 12 months]
- Severe bleeding at 3 and 12 months [Time frame: 3 and 12 months]
- Separate bleeding outcomes at 3 and 12 months [Time frame: 3 and 12 months]
- Major adverse cardiovascular outcomes (MACE) at 3 and 12 months [Time frame: 3 and 12 months]
- Stroke or systemic embolism at 3 and 12 months [Time frame: 3 and 12 months]
- LV thrombus status at 12 months [Time frame: 12 months]
- Net adverse clinical outcomes [Time frame: 3 and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 16 centers
- Falu lasarett — Falun
- Sahlgrenska University hospital, Mölndal — Gothenburg
- Sahlgrenska University hospital, Östra — Gothenburg
- Sahlgrenska University hospital — Gothenburg
- Linköping University hospital — Linköping
- Skånes Universitetssjukhus Lund — Lund
- Skånes University hospital, Malmö — Malmö
- Vrinnevi hospital — Nörrköping
- … and 8 more centers
Identifiers
NCT: NCT06515730 · RESOLVE-AMI