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临床试验/KCT0003380
KCT0003380已完成未知

Early administration of edoxaban after acute ischemic stroke in patients with non-valvular atrial fibrillation: a randomized, multi-center, parallel-group trial

Asan Medical Center0 个研究点目标入组 66 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
已完成
入组人数
66
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

In total, 66 patients (E-group: n=33, C-group: n=33) were enrolled from four tertiary hospitals in South Korea (Asan Medical Center, Kyung Hee University Hospital, Soon Chun Hyang University Hospital, Dong-A University Hospital). There was no difference between the E-group and C-group in terms of demographically, baseline NIHSS, CHADS-2 VAS score, and HAS-BLED scores, and the incidence of thrombolysis/endovascular therapy (Table 1). For the primary endpoint (Table 2), DWI-identified ischemic lesions between days 10–14 occurred in 10 (33.3%) and 6 (19.4%) patients in the E-Group and C-Group, respectively (RR 1.72, 95% CI: 0.72–4.15, P=0.2147). The lesions were all asymptomatic, and none were associated with clinical deterioration (increasing NIHSS =4). For the secondary and safety endpoints, intracranial bleeds detected by GRE occurred in 14 (46.7%) and 17 (54.8%) patients in the E-group and C-group, respectively. Neurological deterioration rate, recanalization rate, and mRS scores at 3 months were not different between the groups

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 0No Limit（—）
性别
All

入选标准

  • •1) Acute ischemic strokes (< 48 h from symptom onset) showing ischemic lesions confirmed by DWI, which are attributable to atrial fibrillation
  • •2) Evidence of persistent or paroxysmal atrial fibrillation (already known or newly detected)
  • •3) Age =20 y
  • •4) Patients who provided informed consent

排除标准

  • •1) Transient ischemic attack with no DWI lesions or severe ischemic strokes (NIHSS >16)
  • •2) Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition or those accompanying with worsening of an existing focal neurological deficit [NIHSS =4])10 on baseline MRI
  • •3) Mechanical heart valve, rheumatic heart valve disease, or any other conditions requiring strong anticoagulation such as vitamin K antagonist or heparin treatment
  • •4) Concomitant significant atherosclerotic stenosis (>50%) in the proximal arteries, which are possibly responsible for stroke lesions
  • •5) Recent (<3 months) history of cerebral bleeding
  • •6) Active internal bleeding or clinically significant bleeding
  • •7) Severe anemia (Hb <10 g/dL) or bleeding diathesis (platelet count <100,000/uL or PT-INR >1.7)(If there is no active bleeding sign, it is permitted to enroll Hb <9 g/dL , platelet count <70,000/uL)
  • •8) Uncontrolled hypertension: persistent systolic pressure >180 mmHg or diastolic pressure >110 mmHg
  • •9) Active, advanced medical diseases (liver, kidney, pulmonary disease or cancer) with a life expectancy <6 months
  • •10) Renal impairment (CrCl <30 mL/min) or undergoing Hemodialysis (or Peritoneal Dialysis)
  • •11) Treatment with a strong inducer of p-glycoprotein (carbamazepine, dexamethasone, doxorubicin, nefazodone, pentobarbital, phenobarbital, prazocin, rifampin, St.John’s wort, tenofovir, tipranavir, trazodone, vinblastine)
  • •12) Contraindication to MRI
  • •13) Pregnancy, breast-feeding or having a plan to be pregnant
  • •14) Participation in the other investigational drug trials simultaneously or within 3 months before the first administration of the study medication. Observational studies without an intervention (eg study medication) are allowed.
  • •15) Any clinical conditions (eg abnormal lab tests) unsuitable for undergoing clinical trials at the discretion of the clinical investigators
  • •16) Known hypersensitivity to the study drug (edoxaban), its ingredients, or formulation excipients
  • •17) Patient with liver disease related to coagulation disorder and clinically significant bleeding risk
  • •18) Severe Liver disease
  • •19) Patient who has increase risk of bleeding due to the following disease
  • •?recent gastrointestinal ulcer history
  • •?carcinoma increased risk of bleeding
  • •?recent brain or spinal injury
  • •?recent brain, spinal or optical surgery histroy
  • •?esophageal varix
  • •?arteriovenous malformations
  • •?vascular aneurysms (over 3.5cm)
  • •?intra spinal or cerebral vascular disorder
  • •20) Patient with other anticoagulants
  • •21) intermitant or severe mitral stenosis
  • •22) a pulmonary embolism patient who is hemodynamic unstabled or required thrombolytic therpy or pulmonary emnolectomy

研究者

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Early administration of edoxaban after acute... | 临床试验