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

Phase 1

• Conditions: intra-cardiac thrombus; MedDRA version: 20.0Level: PTClassification code: 10048620Term: Intracardiac thrombus Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-512685-33-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nimes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

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., Patient =18 years independently of sex or ethnic origin., 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

Exclusion Criteria

Active internal bleeding or recent (< 6 months) major bleeding event requiring surgical procedure or transfusion, 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, Contra-indications mentioned for in SCP (Summary of product characteristics), 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 (creatinine clearance<30ml/min), Known significant liver disease or ALT >3x the ULN, Device related thrombus (mechanical valve prosthesis, left atrial appendage or septal closure devices, pacemaker leads), Patients with mechanical valve prosthesis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the impact of DOA in comparison to VKA (reference treatment) on net clinical benefit at 6 months among patients with intra-cardiac thrombus.;Secondary Objective: To evaluate at 6 and 12 months between patients treated with DOA or VKA the impact on: oAll individual components of the composite primary endpoint oCardiovascular death oAll embolic complications (stroke, embolic myocardial infarction, peripheral artery occlusion, acute pulmonary embolism), To evaluate at 6 and 12 months between patients treated with DOA or VKA the impact on total thrombus regression on cardiac imaging;Primary end point(s): 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 Outcome Measures

Name	Time	Method
Secondary end point(s):-Secondary efficacy endpoints: oAll individual components of the composite ischemic endpoint at 6 and 12 months oSystemic embolism defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism at 6 and 12 months oCardiovascular death at 6 and 12 months oTotal thrombus regression at 6 and 12 months oThrombus recurrence at different cardiac imaging follow-up;Secondary end point(s):-Secondary safety endpoints: oClinically relevant bleedings (international Bleeding Academic Research Consortium (BARC) types 2 to 5) at 6 and 12 months oMajor bleedings (BARC 3 to 5) at 6 and 12 months