EUCTR2015-004847-37-IT进行中（未招募）1 期
A pilot study on Edoxaban for the resolution of left atrial thrombosis in patients with non-valvular atrial fibrillation - Edoxaban in AF
FONDAZIONE G. D'ANNUNZIO, CHIETI0 个研究点目标入组 25 人开始时间: 2021年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with all the following criteria will be eligible for inclusion in the study protocol:
- •1.Signed written informed consent.
- •2.Males and females = 18 years of age.
- •3.Female subjects must be post-menopausal (for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum ß-hCG pregnancy test at screening.
- •4.Atrial fibrillation (AF) must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolment.
- •5.Subjects with newly diagnosed atrial fibrillation are eligible provided that:
- •-there is evidence that the atrial fibrillation is non-valvular:
- •-there is ECG evidence on 2 occasions 24 hours apart demonstrating atrial fibrillation.
- •6.LA or LAA thrombosis documented by trans-esophageal echocardiography (TEE)
- •7.CHA2DS2-VASC score >1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patients with all the following criteria will not be eligible for inclusion in the study protocol:
- •1.Hemodynamically significant mitral valve stenosis.
- •2.Prosthetic heart mechanical or biological valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted).
- •3.Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery or myocardial infarction).
- •4.Known presence of atrial myxoma.
- •5.Left ventricular thrombus.
- •6.Active endocarditis.
- •7.Active internal bleeding.
- •8.History of condition associated with increased bleeding risk including, but not limited to:
- •major surgical procedure or trauma within 30 days;
- •clinically significant gastrointestinal bleeding within 6 months;
- •previous intracranial, intraocular, spinal, atraumatic intra-articular bleeding;
- •chronic haemorrhagic disorder;
- •Any neoplasm, including intracranial neoplasm,
- •arteriovenous malformation or aneurysm.
- •9.Platelet count <90,000/µL at the screening visit.
- •10.Sustained uncontrolled hypertension: SBP =180 mmHg or DBP =100 mmHg.
- •11.Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive within 3 months or any stroke < 14 days).
- •12.Transient ischemic attack within 3 days.
- •13.Treatment with:
- •Any NAO or VKA with optimal INR (optimal = all INR values =2.0 in the previous 30 days)
- •aspirin >160 mg daily;
- •aspirin plus a thienopyridine within 5 days;
- •intravenous antiplatelets within 5 days;
- •fibrinolytics within 10 days.
- •14.Anticipated need for therapy with a non-steroidal anti-inflammatory drug in the next 4 weeks.
- •15.Treatment with a strong inducer of cytochrome P450 and P glycoprotein, such as ritonavir, lopinavir, telaprevir, indinavir or planned treatment during the study.
- •16.Other indication for anticoagulant therapy.
- •17.Hypersensitivity or intolerance to the study drug, including excipients.
- •18.Women of childbearing potential who do not want adopt a contraceptive method during the study period and the following 4 weeks.
- •19.Breast-feeding women during the study period and the following 4 weeks.
- •20.Anemia (hemoglobin <10 g/dL) at the screening visit.
- •21.Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT or AST >2 x ULN or total bilirubin >1.5 x ULN.
- •22.Patients with severe renal impairment (CrCL <30 mL/min) or on dialysis.
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