Assessing management and outcomes of left ventricular thrombus in patients using direct oral anticoagulants
Cohort of Patients With Left Ventricular Thrombus: Management and Outcomes in the Direct Oral Anticoagulants Era
This study is trying to see if patients with left ventricular thrombus who take new blood thinners have fewer bleeding problems compared to those who take traditional blood thinners after a heart attack or heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05028777 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the differences in bleeding events between patients with left ventricular thrombus (LVT) treated with direct oral anticoagulants (DOACs) versus those treated with vitamin K antagonists (VKAs). It focuses on patients who have experienced acute myocardial infarction or chronic heart failure with reduced ejection fraction. The study will analyze data from patients identified with LVT through echocardiography, MRI, or CT from 2013 to 2020, treated at the Inselspital or affiliated sites. The findings could provide insights into the safety and efficacy of anticoagulation strategies in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with left ventricular thrombus through imaging techniques.
Not a fit: Patients who have documented refusal to participate or do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment protocols for patients with left ventricular thrombus, potentially reducing bleeding complications while managing thrombus effectively.
How similar studies have performed: While there is limited evidence on the management of LVT with DOACs, this study explores a relatively novel approach in a specific patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients at least 18 years old at enrolment * With a LVT identified at echocardiography, MRI or CT between January 1st, 2013 and July 31st, 2020 * Treated at least once at the Inselspital or in another site of the Insel Gruppe * Able to provide a written informed consent Exclusion Criteria: * Documented refusal
Where this trial is running
Bern
- Department of Cardiology, University Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christoph Gräni, Prof. PHD — Department of Cardiology, University Hospital Bern
- Study coordinator: Christoph Gräni, Prof. PHD
- Email: christoph.graeni@insel.ch
- Phone: +41 31 632 4508
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.