NCT06515730 Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
| NCT ID | NCT06515730 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Karolinska Institutet |
| Condition | Left Ventricular Thrombus |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2028-04-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 212 participants in total. It began in 2025-04-08 with a primary completion date of 2028-04-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Moa Simonsson, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Medicine Solna, Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06515730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Left Ventricular Thrombus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06515730 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06515730 currently recruiting?
Yes, NCT06515730 is actively recruiting participants. Contact the research team at moa.simonsson@ki.se for enrollment information.
Where is the NCT06515730 trial being conducted?
This trial is being conducted at Falun, Sweden, Gothenburg, Sweden, Gothenburg, Sweden, Gothenburg, Sweden and 11 additional locations.
Who is sponsoring the NCT06515730 clinical trial?
NCT06515730 is sponsored by Karolinska Institutet. The principal investigator is Moa Simonsson, MD, PhD at Department of Medicine Solna, Karolinska Institutet. The trial plans to enroll 212 participants.