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

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003380
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-02
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrent ischemic strokes(The incidence rate of symptomatic or asymptomatic recurrent ischemic strokes on DWI)

Secondary Outcome Measures

Name	Time	Method
The incidence rate of recurrent ischemic lesions with significant clinical worsening (=NIHSS 4);Clinical neurological deterioration(increased =NIHSS 2);Intracranial hemorrhages;Recanalization (full or partial) of occluded vessels;Functional status