Rivaroxaban (with lactose monohydrate excipient listed) for Intracardiac thrombus

Inclusion criteria

• {"criterion_text":"-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."}
• {"criterion_text":"-Patient ≥18 years independently of sex or ethnic origin."}
• {"criterion_text":"-Anticoagulant naïve patient for at least 3 months"}
• {"criterion_text":"-Patient affiliated to a health insurance program"}
• {"criterion_text":"-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."}
• {"criterion_text":"-Patient that signed the consent form"}

Exclusion criteria

• {"criterion_text":"-Active internal bleeding or recent (< 6 months) major bleeding event requiring surgical procedure or transfusion"}
• {"criterion_text":"-Cardiogenic shock"}
• {"criterion_text":"-Pregnancy or breast-feeding patient"}
• {"criterion_text":"-Known allergy or hypersensitivity to VKA or DOA drugs"}
• {"criterion_text":"-Inability or unwillingness to comply with study-related procedures"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Patient under tutorship or curatorship"}
• {"criterion_text":"-Contra-indications mentioned for in SCP (Summary of product characteristics)"}
• {"criterion_text":"-History of intracranial, intraocular, spinal bleeding or known intracranial neoplasm, arteriovenous malformation, or aneurysm"}
• {"criterion_text":"-Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months"}
• {"criterion_text":"-Planned invasive procedure with potential for uncontrolled bleeding"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Severe chronic renal failure (creatinine clearance<30ml/min)"}
• {"criterion_text":"-Known significant liver disease or ALT >3x the ULN"}
• {"criterion_text":"-Device related thrombus (mechanical valve prosthesis, left atrial appendage or septal closure devices, pacemaker leads)"}
• {"criterion_text":"-Patients with mechanical valve prosthesis"}

Primary endpoints

• {"endpoint_text":"-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).","definition_or_measurement_approach":"Composite endpoint assessed at 6 months combining all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings; bleeding classified per BARC (types 2, 3 and 5). All endpoints will be collected from the day of randomization until the end of follow-up."}

Secondary endpoints

• {"endpoint_text":"-\tSecondary efficacy endpoints: o\tAll individual components of the composite ischemic endpoint at 6 and 12 months o\tSystemic embolism defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism at 6 and 12 months o\tCardiovascular death at 6 and 12 months o\tTotal thrombus regression at 6 and 12 months o\tThrombus recurrence at different cardiac imaging follow-up","definition_or_measurement_approach":"Efficacy endpoints assessed at 6 and 12 months; systemic embolism defined as composite of stroke, embolic MI, peripheral artery occlusion and acute pulmonary embolism; total thrombus regression and recurrence assessed by cardiac imaging at specified follow-ups."}
• {"endpoint_text":"-\tSecondary safety endpoints: o\tClinically relevant bleedings (international Bleeding Academic Research Consortium (BARC) types 2 to 5) at 6 and 12 months o\tMajor bleedings (BARC 3 to 5) at 6 and 12 months","definition_or_measurement_approach":"Safety endpoints: clinically relevant bleeds and major bleeds classified per BARC and assessed at 6 and 12 months."}

France

Earliest CTIS Part Ii Submission Date

22-04-2024

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

634

Number Of Sites

1

Number Of Participants

340

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nimes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France