Actively Recruiting
Randomized Comparison of Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
Led by Karolinska Institutet · Updated on 2025-07-01
212
Participants Needed
16
Research Sites
12 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska Trial Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the best anticoagulant treatment for patients who develop left ventricular (LV) thrombus after an acute myocardial infarction (AMI). This study compares the effects of apixaban and warfarin on resolving the thrombus. The trial is a multicenter, randomized Phase 4 study sponsored by Karolinska Institutet, aiming to clarify which medication better supports thrombus resolution in this patient group. Participants are randomly assigned to receive either apixaban or warfarin. Apixaban is given as a 5 mg tablet twice daily, with a reduced dose of 2.5 mg twice daily for certain patients based on age, kidney function, or weight. Warfarin is dosed individually to reach a target blood clotting measure (INR) of 2.0-3.0, with initial bridging using low-molecular-weight heparin. Treatment adjustments are made according to standardized blood tests and patient conditions. During the study, participants undergo evaluations including heart imaging to check thrombus status at 3 and 12 months, and monitoring for bleeding events and major cardiovascular outcomes. The primary outcome is the number and proportion of patients with thrombus resolution at 3 months. Secondary outcomes include bleeding rates, stroke or embolism occurrence, and overall clinical events. The study lasts at least 12 months, providing ongoing safety and efficacy monitoring.
CONDITIONS
Brief Title
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent signing
- Confirmed left ventricular thrombus by transthoracic echocardiography (TTE) within 1 to 28 days after acute myocardial infarction
- Signed informed consent
- For women of childbearing potential: negative pregnancy test, not breastfeeding, and willing to use effective contraception
- For women not of childbearing potential: must be at least 1 year post-menopausal
You will not qualify if you...
- Current anticoagulant treatment for mechanical heart valve, atrial fibrillation, venous thromboembolism, thrombophilia, preexisting LV thrombus, or other reasons
- High bleeding risk including active significant bleeding, chronic bleeding disorder, severe anemia (hemoglobin <80 g/L), or thrombocytopenia (platelet count <80 x 10^9)
- Significant liver disease or hepatic insufficiency classified as Child-Pugh C or D
- Known allergy or intolerance to apixaban or warfarin
- Contraindications to anticoagulants per local labeling
- Participation in another anticoagulant study
- Current alcohol or drug abuse
- Any condition judged unsafe or life expectancy less than 6 months by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 3 months
Participants receive either Apixaban or Warfarin to treat left ventricular thrombus following acute myocardial infarction.
Regular visits for medication monitoring and assessments during the treatment period
Duration - Up to 9 months after treatment (total 12 months from enrollment)
Participants are monitored for bleeding events and cardiovascular outcomes after treatment ends.
Follow-up visits at 3 and 12 months after treatment initiation to assess safety and thrombus status
Trial Site Locations
Total: 16 locations
1
Falu lasarett
Falun, Sweden
Not Yet Recruiting
2
Sahlgrenska University hospital, Mölndal
Gothenburg, Sweden
Not Yet Recruiting
3
Sahlgrenska University hospital, Östra
Gothenburg, Sweden
Not Yet Recruiting
4
Sahlgrenska University hospital
Gothenburg, Sweden
Not Yet Recruiting
5
Linköping University hospital
Linköping, Sweden
Not Yet Recruiting
6
Skånes Universitetssjukhus Lund
Lund, Sweden
Actively Recruiting
7
Skånes University hospital, Malmö
Malmö, Sweden
Not Yet Recruiting
8
Vrinnevi hospital
Nörrköping, Sweden
Not Yet Recruiting
9
Örebro University hospital
Örebro, Sweden
Not Yet Recruiting
10
Karolinska Insitutet
Stockholm, Sweden, 17177
Actively Recruiting
11
Danderyds hospital
Stockholm, Sweden
Not Yet Recruiting
12
Karolinska Univerity Hospital
Stockholm, Sweden
Actively Recruiting
13
Sankt Görans Hospital
Stockholm, Sweden
Not Yet Recruiting
14
Södersjukhuset
Stockholm, Sweden
Not Yet Recruiting
15
Uppsala Akademiska hospital
Uppsala, Sweden
Not Yet Recruiting
16
Västmanlands hospital, Västerås
Västerås, Sweden
Not Yet Recruiting
Research Team
E
Eva Olofsson
S
Stina Smetana
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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