Status:
COMPLETED
Early Administration of Edoxaban After Acute Ischemic Stroke in Patients With Non-valvular Atrial Fibrillation
Lead Sponsor:
Jong Sung Kim
Collaborating Sponsors:
Kyung Hee University Hospital
Soon Chun Hyang University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that earlier initiation of edoxaban in AF-related stroke patients may significantly reduce the early recurrence of ischemic stroke, compared with conventional strategy of...
Detailed Description
In patients with ischemic stroke and atrial fibrillation (AF), the risk of stroke recurrence is high, especially shortly after the event. Because AF-related strokes are usually larger in their size an...
Eligibility Criteria
Inclusion
- Acute ischemic strokes (\< 48 h from symptom onset) showing ischemic lesions confirmed by DWI, which are attributable to atrial fibrillation
- Evidence of persistent or paroxysmal atrial fibrillation (already known or newly detected)
- Age ≥20 y
- Patients who provided informed consent
Exclusion
- Transient ischemic attack with no DWI lesions or severe ischemic strokes (NIHSS \>16)
- 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
- Mechanical heart valve, rheumatic heart valve disease, or any other conditions requiring strong anticoagulation such as vitamin K antagonist or heparin treatment
- Concomitant significant atherosclerotic stenosis (\>50%) in the proximal arteries, which are possibly responsible for stroke lesions
- Recent (\<3 months) history of cerebral bleeding
- Active internal bleeding or clinically significant bleeding
- 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)
- Uncontrolled hypertension: persistent systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg
- Active, advanced medical diseases (liver, kidney, pulmonary disease or cancer) with a life expectancy \<6 months
- Renal impairment (CrCl \<30 mL/min) or undergoing Hemodialysis (or Peritoneal Dialysis)
- Treatment with a strong inducer of p-glycoprotein (carbamazepine, dexamethasone, doxorubicin, nefazodone, pentobarbital, phenobarbital, prazocin, rifampin, St.John's wort, tenofovir, tipranavir, trazodone, vinblastine)
- Contraindication to MRI
- Pregnancy, breast-feeding or having a plan to be pregnant
- 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.
- Any clinical conditions (eg abnormal lab tests) unsuitable for undergoing clinical trials at the discretion of the clinical investigators
- Known hypersensitivity to the study drug (edoxaban), its ingredients, or formulation excipients
- Patient with liver disease related to coagulation disorder and clinically significant bleeding risk
- Severe Liver disease
- 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
- Patient with other anticoagulants
- intermitant or severe mitral stenosis
- a pulmonary embolism patient who is hemodynamic unstabled or required thrombolytic therpy or pulmonary emnolectomy
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03433235
Start Date
June 19 2018
End Date
July 2 2020
Last Update
December 11 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea