Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus (ARGONAUT)
Intracardiac Thrombus, STEMI, Heart Failure
About this trial
This is an interventional treatment trial for Intracardiac Thrombus focused on measuring anticoagulation therapy, direct oral anticoagulant, stroke, acute coronary syndrome, embolism
Eligibility Criteria
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
Sites / Locations
- CHU AngersRecruiting
- CH de la Région Annecienne
- Ch AvignonRecruiting
- CH Bastia
- Hôpital Cardiologique du Haut LévêqueRecruiting
- CHU Brest
- CH ChartresRecruiting
- CHU Gabriel MontpiedRecruiting
- CH Compiègne Noyon
- Hôpital Privé Dijon BourgogneRecruiting
- Groupe Hospitalier MutualisteRecruiting
- CHU LilleRecruiting
- CHU LimogesRecruiting
- Hôpital Cardiovasculaire Louis PradelRecruiting
- AP-HM CHU La Timone
- CHR Metz-ThionvilleRecruiting
- CHU Arnaud de VilleneuveRecruiting
- Clinique du MillenaireRecruiting
- CHU Nantes
- CHU NiceRecruiting
- CHU de NimesRecruiting
- AP-HP CHU Bichat
- AP-HP CHU Lariboisière
- Ap-Hp HegpRecruiting
- AP-HP Hopital Ambroise Paré
- CHU Pitié-SalpêtrièreRecruiting
- CH Francois MitterandRecruiting
- CH Joffre Perpignan
- CHU PoitiersRecruiting
- CHU Rennes
- Centre Cardiologique du Nord
- CHU Strasbourg
- CHU ToulouseRecruiting
- CHU La réunion NORDRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Reference treatment
Direct Oral Anticoagulant