BridgeMD
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
EU CTIS ID: 2024-512685-33-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.