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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Apr 11, 2023

Keywords

ClinConnect Summary

The ARGONAUT trial is studying how well a new type of blood thinner, called Direct Oral Anticoagulants (DOA), works compared to traditional blood thinners known as Vitamin K Antagonists (VKA) in patients with a specific heart condition called intracardiac thrombus (a blood clot inside the heart). This trial aims to see which medication helps reduce the size of these clots and improves health outcomes for patients, regardless of where the clot is located in the heart or any underlying heart disease.

To be eligible for this study, participants need to be diagnosed with a non-device-related intracardiac thrombus and must not have taken any blood thinners for at least three months. They should also be between the ages of 65 and 74 and be willing to sign a consent form to participate. If someone joins the study, they can expect to receive either the new DOA or the traditional VKA while being closely monitored for any changes in their condition over the course of the trial. It’s important to note that certain individuals, such as those with recent major bleeding events or severe kidney or liver issues, will not be eligible to participate for their safety.

Gender

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Eligibility criteria

• 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.
• • 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
• • 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