Apixaban versus warfarin for left ventricular clot after a heart attack
RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
This compares apixaban and warfarin to see which better clears left-ventricular blood clots in adults after a heart attack.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 16 sites (Falun and 15 other locations) |
| Trial ID | NCT06515730 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized phase 4 study enrolls adults who develop a left ventricular thrombus within 1–28 days after an acute myocardial infarction. Participants are randomly assigned to receive apixaban or warfarin and are followed with transthoracic echocardiography to document thrombus resolution. Key exclusions include patients already requiring anticoagulation for other conditions or those with high bleeding risk, severe anemia, or thrombocytopenia. The trial measures thrombus resolution as the primary outcome and records bleeding and other safety events as secondary outcomes.
Who should consider this trial
Good fit: Adults (≥18) with a transthoracic echo–confirmed left ventricular thrombus 1–28 days after a heart attack who are not already on long-term anticoagulation and can give informed consent.
Not a fit: Patients who require anticoagulation for other reasons (mechanical valves, atrial fibrillation, venous thromboembolism, thrombophilia), those with high bleeding risk, severe anemia or thrombocytopenia, pregnant or breastfeeding women, or those already treated for an LV thrombus are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the study could identify a simpler or safer anticoagulant option that clears ventricular clots effectively and lowers complication risk compared with current warfarin management.
How similar studies have performed: Small observational studies and case series suggest direct oral anticoagulants like apixaban may resolve LV thrombus, but randomized comparative data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Falun and 15 other locations
- Falu lasarett — Falun, Sweden (Not_yet_recruiting)
- Sahlgrenska University hospital, Mölndal — Gothenburg, Sweden (Not_yet_recruiting)
- Sahlgrenska University hospital, Östra — Gothenburg, Sweden (Not_yet_recruiting)
- Sahlgrenska University hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Linköping University hospital — Linköping, Sweden (Not_yet_recruiting)
- Skånes Universitetssjukhus Lund — Lund, Sweden (Recruiting)
- Skånes University hospital, Malmö — Malmö, Sweden (Not_yet_recruiting)
- Vrinnevi hospital — Nörrköping, Sweden (Not_yet_recruiting)
- Örebro University hospital — Örebro, Sweden (Not_yet_recruiting)
- Karolinska Insitutet — Stockholm, Sweden (Recruiting)
- Danderyds hospital — Stockholm, Sweden (Not_yet_recruiting)
- Karolinska Univerity Hospital — Stockholm, Sweden (Recruiting)
- Sankt Görans Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Södersjukhuset — Stockholm, Sweden (Not_yet_recruiting)
- Uppsala Akademiska hospital — Uppsala, Sweden (Not_yet_recruiting)
- Västmanlands hospital, Västerås — Västerås, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Moa Simonsson, MD, PhD — Department of Medicine Solna, Karolinska Institutet
- Study coordinator: Eva Olofsson
- Email: moa.simonsson@ki.se
- Phone: +46707780897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.