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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 – the ARGONAUT trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512685-33-00
Acronym
PHRC-N/2020/BL-01
Enrollment
340
Registered
2024-05-14
Start date
2023-04-11
Completion date
Unknown
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intra-cardiac thrombus

Brief summary

Net clinical benefit endpoint at 6 months: composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (Bleeding Academic Research Consortium 2, 3 and 5).

Detailed description

- Secondary efficacy endpoints: o All individual components of the composite ischemic endpoint at 6 and 12 months o Systemic embolism defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism at 6 and 12 months o Cardiovascular death at 6 and 12 months o Total thrombus regression at 6 and 12 months o Thrombus recurrence at different cardiac imaging follow-up, - Secondary safety endpoints: o Clinically relevant bleedings (international Bleeding Academic Research Consortium (BARC) types 2 to 5) at 6 and 12 months o Major bleedings (BARC 3 to 5) at 6 and 12 months

Interventions

DRUGRIVAROXABAN
DRUGPREVISCAN 20 mg comprimé quadrisécable
DRUGDABIGATRAN ETEXILATE
DRUGAPIXABAN
DRUGWARFARIN

Sponsors

Centre Hospitalier Universitaire De Nimes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Net clinical benefit endpoint at 6 months: composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (Bleeding Academic Research Consortium 2, 3 and 5).

Secondary

MeasureTime frame
- Secondary efficacy endpoints: o All individual components of the composite ischemic endpoint at 6 and 12 months o Systemic embolism defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism at 6 and 12 months o Cardiovascular death at 6 and 12 months o Total thrombus regression at 6 and 12 months o Thrombus recurrence at different cardiac imaging follow-up, - Secondary safety endpoints: o Clinically relevant bleedings (international Bleeding Academic Research Consortium (BARC) types 2 to 5) at 6 and 12 months o Major bleedings (BARC 3 to 5) at 6 and 12 months

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026