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Anticoagulant Regimens Given to Achieve Thrombus Regression and Reduce Clinical Outcomes Among Patients With Non Device-related Intra-cardiac Thrombus: a Randomized Assessment Under Direct Oral Anticoagulant and Vitamin-k Antagonist Therapy
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 similar thrombus regression following DOA in comparison to VKA and similar ischemic outcomes although no head-to-head comparison would be powered. As a consequence, the multicentric randomized ARGONAUT trial aims to confirm these results and evaluate the impact of DOA compared to VKA on thrombus regression and clinical outcomes among patients with intracardiac thrombus, regardless of the thrombus localization and any underlying heart disease.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 15, 2023
Primary Completion Date
February 5, 2025
Completion Date
February 1, 2026
Last Updated
February 17, 2026
340
ESTIMATED participants
Vitamin K antagonist
DRUG
Direct oral anticoagulant
DRUG
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
NCT06647069
NCT07484009
Data Source & Attribution
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