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An investigator-initiated, multicenter, open-label, parallel arm, active comparator, randomized study to compare the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with left ventricular thrombus after acute myocardial infarction.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514416-28-00
Enrollment
212
Registered
2024-11-04
Start date
2025-04-09
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute mycocardial infarction (AMI), Left ventricular thrombosis.

Brief summary

Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.

Detailed description

Clinically relevant bleeding - BARC (Bleeding Academy Research Consortium) 2, 3 or 5 bleeding., Major bleeding BARC 3 or 5 bleeding., Individual bleeding endpoints (Fatal bleeding, intracranial hemorrhage, GI bleeding, urogenital bleeding and bleeding of other sources)., Major adverse cardiovascular events (MACE). Composite of non-fatal myocardial infarction, non-fatal ischemic stroke and cardiovascular death., Net clinical benefit: Composite of MACE and BARC 2, 3 or 5 bleeding., Ischemic stroke and systemic embolism., Recurrence of LV thrombus at 12 months.

Interventions

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.

Secondary

MeasureTime frame
Clinically relevant bleeding - BARC (Bleeding Academy Research Consortium) 2, 3 or 5 bleeding., Major bleeding BARC 3 or 5 bleeding., Individual bleeding endpoints (Fatal bleeding, intracranial hemorrhage, GI bleeding, urogenital bleeding and bleeding of other sources)., Major adverse cardiovascular events (MACE). Composite of non-fatal myocardial infarction, non-fatal ischemic stroke and cardiovascular death., Net clinical benefit: Composite of MACE and BARC 2, 3 or 5 bleeding., Ischemic stroke and systemic embolism., Recurrence of LV thrombus at 12 months.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026