Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus

Last updated: July 22, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

Direct oral anticoagulant

Vitamin K antagonist

Clinical Study ID

NCT05825573
PHRC-N/2020/BL-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with a non-device related intra-cardiac thrombus (all localizations in thefour cavities) diagnosed by echocardiography, cardiac CT-scanner or cardiac magneticresonance 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 studymedication until the one-year follow-up visit. Registries and studies not involvinga study drug are allowed.

  • Patient that signed the consent form

Exclusion

Exclusion Criteria:

  • Active internal bleeding or recent (< 6 months) major bleeding event requiringsurgical procedure or transfusion

  • History of intracranial, intraocular, spinal bleeding or known intracranialneoplasm, arteriovenous malformation, or aneurysm

  • Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3months

  • Planned invasive procedure with potential for uncontrolled bleeding

  • Impaired hemostasis such as known International Normalized Ratio (INR) >1.5; past orpresent bleeding disorder (including congenital bleeding disorders such as vonWillebrand's disease or hemophilia, acquired bleeding disorders, and unexplainedclinically 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 orseptal 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 investigationalagents or devices within the previous 30 days, planned use of investigational drugsor devices, or previous enrolment in this trial (participation in a trial of routinecare is authorized at the same time)

  • Patient under tutorship or curatorship

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: Direct oral anticoagulant
Phase: 3
Study Start date:
May 15, 2023
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • CH de la Région Annecienne

    Annecy,
    France

    Site Not Available

  • Ch Auxerre

    Auxerre, 89000
    France

    Site Not Available

  • Ch Avignon

    Avignon,
    France

    Active - Recruiting

  • CH Bastia

    Bastia,
    France

    Active - Recruiting

  • Hôpital Cardiologique du Haut Lévêque

    Bordeaux,
    France

    Active - Recruiting

  • CHU Brest

    Brest,
    France

    Site Not Available

  • CH Chartres

    Chartres,
    France

    Active - Recruiting

  • CHU Gabriel Montpied

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CH Compiègne Noyon

    Compiègne,
    France

    Active - Recruiting

  • Hôpital Privé Dijon Bourgogne

    Dijon,
    France

    Active - Recruiting

  • Groupe Hospitalier Mutualiste

    Grenoble,
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • CHU Limoges

    Limoges,
    France

    Active - Recruiting

  • Hôpital Cardiovasculaire Louis Pradel

    Lyon,
    France

    Active - Recruiting

  • AP-HM CHU La Timone

    Marseille,
    France

    Active - Recruiting

  • CHR Metz-Thionville

    Metz,
    France

    Active - Recruiting

  • CHU Arnaud de Villeneuve

    Montpellier,
    France

    Active - Recruiting

  • Clinique du Millenaire

    Montpellier,
    France

    Active - Recruiting

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • CHU Nice

    Nice,
    France

    Active - Recruiting

  • CHU de Nimes

    Nîmes,
    France

    Active - Recruiting

  • AP-HP CHU Bichat

    Paris,
    France

    Site Not Available

  • AP-HP CHU Lariboisière

    Paris,
    France

    Active - Recruiting

  • AP-HP Hopital Ambroise Paré

    Paris,
    France

    Active - Recruiting

  • Ap-Hp Hegp

    Paris,
    France

    Active - Recruiting

  • CHU Pitié-Salpêtrière

    Paris,
    France

    Active - Recruiting

  • CH Francois Mitterand

    Pau,
    France

    Active - Recruiting

  • CH Joffre Perpignan

    Perpignan,
    France

    Site Not Available

  • CHU Poitiers

    Potiers,
    France

    Active - Recruiting

  • CHU Rennes

    Rennes,
    France

    Active - Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis,
    France

    Active - Recruiting

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • Centre Hopistalier de Valence

    Valence, 26000
    France

    Site Not Available

  • Ch Bretagne Atlantique

    Vannes, 56000
    France

    Site Not Available

  • CHU La réunion NORD

    Saint-Denis,
    Réunion

    Active - Recruiting

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