EICHORCondition: Intracardiac Thrombus · STEMI · Heart Failure · Sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
Left ventricular thrombus is found in 10 to 25% of patients with impaired left ventricular function following ST-segment elevation myocardial infarction and up to 20% in dilated cardiomyopathy in observational studies. Likewise, the incidence of atrial thrombus among atrial fibrillation patients treated by vitamin K antagonist (VKA) is between 0.25% and 7%. Despite anticoagulant therapy, intra-cardiac thrombus remains a severe complication associated with a high risk of systemic embolism and subsequent mortality but also bleeding events related to the anticoagulation therapy. The class of non-vitamin K antagonist direct oral anticoagulant (DOA) has emerged in the last decades and has systematically surpassed VKA in the different clinical settings by providing at minimum a similar efficacy and a better safety profile. In the absence of randomized study in the specific clinical setting of intracardiac thrombus, international Guidelines recommend, on the basis of expert opinion, the use of VKA for at least 3 to 6 months in case of left ventricular thrombus and there is no specific recommendation for thrombus management from other cardiac localizations. In comparison to VKA, the easier management and the large evidence of better safety of DOA make it an interesting anticoagulant strategy. Data for left ventricule thrombosis treatment are limited and only supported by observational cohorts. However, these recent cohorts have shown promising data in this indication reporting simil…
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Patient with a non-device related intra-cardiac thrombus (all localizations in the four cavities) diagnosed by echocardiography, cardiac CT-scanner or cardiac magnetic resonance imaging independently of underlying heart disease. * Anticoagulant naïve patient for at least 3 months * Patient affiliated to a health insurance program * Patient that accepted not to participate in other studies involving a study medication until the one-year follow-up visit. Registries and studies not involving a study drug are allowed. * Patient that signed the consent form Exclusion Criteria: * Active internal bleeding or recent (\< 6 months) major bleeding event requiring surgical procedure or transfusion * History of intracranial, intraocular, spinal bleeding or known intracranial neoplasm, arteriovenous malformation, or aneurysm * Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months * Planned invasive procedure with potential for uncontrolled bleeding * Impaired hemostasis such as known International Normalized Ratio (INR) \>1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/μL) * Severe chronic renal failure (creat. clearance\<30ml/min) * Known significant liver disease * Device related thrombus (mechanical valve prosthesis, left atrial appendage or septal closure devices, pacemaker leads) * Patients with mechanical valve prosthesis * Cardiogenic shock * Pregnancy or breast-feeding patient * Known allergy or hypersensitivity to VKA or DOA drugs * Inability or unwillingness to comply with study-related procedures * Participation in another clinical research protocol with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial (participation in a trial of routine care is authorized at the same time) * Patient under tutorship or curatorship
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| CHU Angers | Angers, France | — |
| Ch Auxerre | Auxerre, France | — |
| Ch Avignon | Avignon, France | — |
| CH Bastia | Bastia, France | — |
| Hôpital Cardiologique du Haut Lévêque | Bordeaux, France | — |
| CHU Brest | Brest, France | — |
| CH Chartres | Chartres, France | — |
| CHU Gabriel Montpied | Clermont-Ferrand, France | — |
| CH Compiègne Noyon | Compiègne, France | — |
| Hôpital Privé Dijon Bourgogne | Dijon, France | — |
| Groupe Hospitalier Mutualiste | Grenoble, France | — |
| CHU Lille | Lille, France | — |
+ 23 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05825573