CTIS2024-512685-33-00
Active, not recruiting
Phase 1
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 - PHRC-N/2020/BL-01
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- intra-cardiac thrombus
- Sponsor
- Centre Hospitalier Universitaire De Nimes
- Enrollment
- 340
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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., 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
Outcomes
Primary Outcomes
Not specified
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