Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus
ARGONAUT
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
1 other identifier
interventional
340
2 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2023
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFebruary 17, 2026
February 1, 2026
1.7 years
April 11, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus
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)
6 months
Secondary Outcomes (22)
All cause death between groups
6 months
All cause death between groups
12 months
Myocardial infarction occurrence between groups
6 months
Myocardial infarction occurrence between groups
12 months
Stroke occurrence between groups
6 months
- +17 more secondary outcomes
Study Arms (2)
Reference treatment
ACTIVE COMPARATORDirect Oral Anticoagulant
EXPERIMENTALInterventions
VKA study medications (Warfarin, Fluindione and Acenocoumarol) will be prescribed and supplied in the usual setting of patient care with respect of the international guidelines and recommended dose protocols and will not be specifically supplied for the trial. Anticoagulant treatment will be prescribed for 6 months. The recommended INR target will be \[2-3\] and \[2-2.5\] for patients treated with concomitant antiplatelet therapy. Biological monitoring will be performed at discretion of physicians as usual care.
DOA study medications (Apixaban, Rivaroxaban and Dabigatran) will be prescribed and supplied in the usual setting of patient care and will not be specifically supplied for the trial. The usual doses of DOA will be prescribed: dabigatran 150mg twice a day, apixaban 5mg twice a day and rivaroxaban 20mg once a day. The adjusted doses (dabigatran 110mg twice a day, apixaban 2.5mg twice a day and rivaroxaban 15mg once a day) will be prescribed according to clinical practice treatment guidelines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
CHU Angers
Angers, France
Ch Auxerre
Auxerre, 89000, 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
CHU Limoges
Limoges, France
Hôpital Cardiovasculaire Louis Pradel
Lyon, France
AP-HM CHU La Timone
Marseille, France
CHR Metz-Thionville
Metz, France
CHU Arnaud de Villeneuve
Montpellier, France
Clinique du Millenaire
Montpellier, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
CHU de Nimes
Nîmes, France
AP-HP CHU Bichat
Paris, France
AP-HP CHU Lariboisière
Paris, France
Ap-Hp Hegp
Paris, France
AP-HP Hopital Ambroise Paré
Paris, France
CHU Pitié-Salpêtrière
Paris, France
CH Francois Mitterand
Pau, France
CHU Poitiers
Potiers, France
CHU Rennes
Rennes, France
Centre Cardiologique du Nord
Saint-Denis, France
CHU Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
Centre Hopistalier de Valence
Valence, 26000, France
Ch Bretagne Atlantique
Vannes, 56000, France
CHU La réunion NORD
Saint-Denis, Reunion
Related Publications (1)
Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.
PMID: 32273033BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
benoit.lattuca@chu-nimes.fr Lattuca
CHU Nimes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2023
First Posted
April 24, 2023
Study Start
May 15, 2023
Primary Completion
February 5, 2025
Study Completion
February 1, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02