CTIS2024-512685-33-00进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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