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

Study acronym: ARGONAUT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv8
  2. Minor Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Apr 2025 to Feb 5, 2025 · Completion date: Apr 2025 to Feb 2026 · Site details revised at 35 of 35 sitesv7 Show 3 more changesShow less
    • Primary completion date changed from estimate of Apr 2025 to Feb 5, 2025
    • Completion date: Apr 2025 to Feb 2026
    • Site details revised at 35 of 35 sites
  3. Minor Site contacts updated at 2 of 35 sitesv6
  4. Minor Study sites: 33 to 35v5
  5. Minor Study sites: 34 to 33v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2023 to May 15, 2023 · Site details revised at 34 of 34 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of May 2023 to May 15, 2023
    • Site details revised at 34 of 34 sites
  2. Minor Start date: Apr 2023 to May 2023v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05825573
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Intracardiac Thrombus, STEMI, Heart Failure
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov