Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus
- Conditions
- Intracardiac ThrombusHeart FailureSTEMI
- Interventions
- Drug: Direct oral anticoagulant
- Registration Number
- NCT05825573
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Direct Oral Anticoagulant Direct oral anticoagulant - Reference treatment Vitamin K antagonist -
- Primary Outcome Measures
Name Time Method Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus 6 months Composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (BARC 2 to 5 bleedings)
- Secondary Outcome Measures
Name Time Method All cause death between groups 12 months Any death documented during the follow-up independently of cause of death
Myocardial infarction occurrence between groups 12 months All non-fatal MI, excluding MI type 3, which will be captured separately as death
Stroke occurrence between groups 12 months Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Acute peripheral emboli occurrence between groups 12 months All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing
Acute pulmonary embolism occurrence between groups 12 months Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines
Thrombus persistence between groups 12 months Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression
Clinically relevant bleedings between groups 12 months International Bleeding Academic Research Consortium (BARC) types 2 to 5
Systemic embolism between groups 12 months defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Cardiovascular death between groups 12 months Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided.
Total thrombus recurrence between groups 12 months Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Major bleedings between groups 12 months International Bleeding Academic Research Consortium (BARC) types 3 to 5
Trial Locations
- Locations (35)
CH Compiègne Noyon
🇫🇷Compiègne, France
CHU Angers
🇫🇷Angers, France
CH Chartres
🇫🇷Chartres, France
CH Bastia
🇫🇷Bastia, France
CHU La réunion NORD
🇷🇪Saint-Denis, Réunion
AP-HM CHU La Timone
🇫🇷Marseille, France
CHU Nice
🇫🇷Nice, France
CHU Pitié-Salpêtrière
🇫🇷Paris, France
Hôpital Cardiologique du Haut Lévêque
🇫🇷Bordeaux, France
CHU Brest
🇫🇷Brest, France
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hôpital Cardiovasculaire Louis Pradel
🇫🇷Lyon, France
Hôpital Privé Dijon Bourgogne
🇫🇷Dijon, France
CHU Lille
🇫🇷Lille, France
CHR Metz-Thionville
🇫🇷Metz, France
CHU Arnaud de Villeneuve
🇫🇷Montpellier, France
AP-HP CHU Bichat
🇫🇷Paris, France
AP-HP CHU Lariboisière
🇫🇷Paris, France
CHU Nantes
🇫🇷Nantes, France
Ap-Hp Hegp
🇫🇷Paris, France
CH Francois Mitterand
🇫🇷Pau, France
CHU Poitiers
🇫🇷Potiers, France
CHU Rennes
🇫🇷Rennes, France
CHU Strasbourg
🇫🇷Strasbourg, France
CHU Toulouse
🇫🇷Toulouse, France
Centre Hopistalier de Valence
🇫🇷Valence, France
Ch Bretagne Atlantique
🇫🇷Vannes, France
Ch Auxerre
🇫🇷Auxerre, France
Groupe Hospitalier Mutualiste
🇫🇷Grenoble, France
AP-HP Hopital Ambroise Paré
🇫🇷Paris, France
Centre Cardiologique du Nord
🇫🇷Saint-Denis, France
CHU de Nimes
🇫🇷Nîmes, France
Ch Avignon
🇫🇷Avignon, France
CHU Limoges
🇫🇷Limoges, France
Clinique du Millenaire
🇫🇷Montpellier, France