Left Ventricular ThrombusPhase 4RESOLVE-AMINCT06515730
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
A Phase 4 study testing Apixaban and Warfarin in people with Left Ventricular Thrombus and Acute Myocardial Infarction, run by Karolinska Institutet at 16 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Thrombus, Acute Myocardial Infarction
- What is being tested?
- Apixaban and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 16 sitesSweden
- Study dates
- 8 Apr 2025to 1 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Sweden16 sites, 16 recruiting
- Not yet recruiting
Falu lasarett
Falun
Elin Falås, MD, +46 23 49 00 00, elin.falas@gmail.com
- Not yet recruiting
Sahlgrenska University hospital, Mölndal
Gothenburg
Georgios Mourtzinis, MD, PhD, +46 31 342 10 00, georgios.mourtzinis@vgregion.se
- Not yet recruiting
Sahlgrenska University hospital, Östra
Gothenburg
Katarina Glise-Sandblad Glise Sandblad, MD, PhD, +46 31 342 10 00, katarina.glise.sandblad@vgregion.se
- Not yet recruiting
Sahlgrenska University hospital
Gothenburg
Annica Ravn-Fischer, MD, PhD, +46 31 342 10 00, annica.ravn-fischer@vgregion.se
- Not yet recruiting
Linköping University hospital
Linköping
Mats Pettersson, MD, PhD, +46 10 103 00 00, Mats.Pettersson@regionostergotland.se
- Recruiting
Skånes Universitetssjukhus Lund
Lund
Josef Dankiewicz, MD, PhD, + 46 4617 10 00, josef.dankiewicz@gmail.com
- Not yet recruiting
Skånes University hospital, Malmö
Malmö
Helena Grauen Larsen, MD, PhD, +46 40 33 10 00, Helena.GrauenLarsen@skane.se
- Not yet recruiting
Vrinnevi hospital
Nörrköping
Malgorzata Pierscinska-Jedra, MD, +46 10 103 00 00, Malgorzata.Pierscinska-Jedra@regionostergotland.se
- Not yet recruiting
Örebro University hospital
Örebro
Robin Gustafsson, MD, PhD, +46 19 602 10 00, robin.gustafsson@regionorebrolan.se
- Recruiting
Karolinska Insitutet
Stockholm, 17177
Moa Simonsson, MD, PhD, +46707411272, moa.simonsson@regionstockholm.se
- Not yet recruiting
Danderyds hospital
Stockholm
Mika Skeppholm, + 46 8 123 550 00, mika.skeppholm@regionstockholm.se
- Recruiting
Karolinska Univerity Hospital
Stockholm
Moa Simonsson, MD, PhD, +46 707411272, moa.simonsson@ki.se
- Not yet recruiting
Sankt Görans Hospital
Stockholm
Emil Grönlund, MD, +46 8 587 010 00, emil.gronlund@capiostgoran.se
- Not yet recruiting
Södersjukhuset
Stockholm
Robin Hofmann, MD, PhD, +46 8 123 610 00, robin.hofmann@regionstockholm.se
- Not yet recruiting
Uppsala Akademiska hospital
Uppsala
Christina Christersson, +46 18 611 00 00, Christina.Christersson@medsci.uu.se
- Not yet recruiting
Västmanlands hospital, Västerås
Västerås
Anders Nordfors, MD, PhD, +46 21 17 30 00, anders.nordfors@regionvastmanland.se
About this study
Official title: RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
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.
- Keywords
- Apixaban, warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
5 mg tablet twice a daily with dose reduction according to label
WarfarinDrug
Also called Waran
2.5 mg tablet once daily, with individual dosing according to coagulation tests
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | 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. Receives: Drug: Apixaban |
| Warfarin | Active comparator | 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. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants with thrombus resolution at 3 months
Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE*) at 3 months
Measured: 3 months
Secondary outcomes (7)
Clinically relevant bleeding at 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.
Measured: 3 and 12 months
Severe bleeding at 3 and 12 months
Severe bleeding defined as BARC 3 or 5. For definition of the BARC bleeding scale please see Outcome 2 above.
Measured: 3 and 12 months
Separate bleeding outcomes at 3 and 12 months
Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding
Measured: 3 and 12 months
Major adverse cardiovascular outcomes (MACE) at 3 and 12 months
MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death
Measured: 3 and 12 months
Stroke or systemic embolism at 3 and 12 months
Composite of ischemic stroke or systemic embolism
Measured: 3 and 12 months
LV thrombus status at 12 months
Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months
Measured: 12 months
Net adverse clinical outcomes
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.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start8 Apr 2025
- Primary completion8 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular ThrombusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, multicenter, open-label, blinded outcome assessment, parallel arm, active comparator, randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Trial Alliance, Swedish Heart Lung Foundation, The Swedish Research Council, Stockholm County Council ALF/PPG
- Responsible party
- Principal investigator, Moa Simonsson, Karolinska Institutet
- Investigators
- Moa Simonsson, MD, PhD, Principal investigator, Department of Medicine Solna, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515730
- Sponsor's protocol ID
- RESOLVE-AMI
- Acronym
- RESOLVE-AMI
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
- ClinicalTrials.gov ID
- NCT06515730
- Acronym / sponsor ID
- RESOLVE-AMI / RESOLVE-AMI
- Keywords
- Apixaban, warfarin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska Trial Alliance, Swedish Heart Lung Foundation, The Swedish Research Council, Stockholm County Council ALF/PPG
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigator-initiated, multicenter, open-label, blinded outcome assessment, parallel arm, active comparator, randomized study
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: ApixabanApixaban 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 | Active comparator | Drug: WarfarinWarfarin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: Eliquis5 mg tablet twice a daily with dose reduction according to label | Drug | Apixaban |
| WarfarinAlso: Waran2.5 mg tablet once daily, with individual dosing according to coagulation tests | Drug | Warfarin |
Primary outcome
Number and proportion of participants with thrombus resolution at 3 months
Time frame: 3 months
Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE*) at 3 months
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moa Simonsson, MD, PhD principal investigator
Department of Medicine Solna, Karolinska Institutet
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban and Warfarin in people with Left Ventricular Thrombus and Acute Myocardial Infarction, run by Karolinska Institutet at 16 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Olofsson (+46707780897, moa.simonsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of participants with thrombus resolution at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.