COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Edoxaban for TIA and Acute Minor Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02221102
Recruitment Status : Unknown
Verified August 2014 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:

Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage.

This trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.

Condition or disease Intervention/treatment Phase
Ischemia Stroke Cerebral Infarction Drug: Aspirin Drug: edoxaban Drug: placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Edoxaban Versus Aspirin for Non-disabling Cerebrovascular Events: Rationale, Objectives, and Design
Study Start Date : December 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: aspirin
Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30
Drug: Aspirin
non-steroidal anti-inflammatory drugs
Other Name: Acetylsalicylic acid

Drug: placebo
Experimental: edoxaban 30mg
Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30
Drug: edoxaban
orally active direct factor Xa inhibitor
Other Names:
  • DU176b

Drug: placebo
Experimental: edoxaban 60mg
Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30
Drug: edoxaban
orally active direct factor Xa inhibitor
Other Names:
  • DU176b

Drug: placebo

Primary Outcome Measures :
  1. percentage of patients with new stroke (ischemic or hemorrhage) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) [ Time Frame: 30 days ]
  2. mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6 [ Time Frame: 30 days and 90 days ]
  3. Changes in NIHSS scores [ Time Frame: 90 days ]
  4. moderate to severe bleeding events [ Time Frame: 90 days ]
  5. Total mortality [ Time Frame: 90 days ]
  6. Adverse events/severe adverse events reported by the investigators [ Time Frame: 90 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult subjects (male or female ≥18 years old)
  • Acute nondisabling ischemic stroke (NIHSS ≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
  • TIA (neurologic deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with investigational medication within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
  • Informed consent signed

Exclusion Criteria:

  • Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease, on baseline head CT or MRI scan
  • mRS score >2 at randomization (premorbid historical assessment)
  • NIHSS ≥4 at randomization
  • Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state)
  • Contraindication to investigational medications
  • Thrombolysis for ischemic stroke within preceding 7 days
  • History of intracranial hemorrhage
  • Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anticoagulation
  • Gastrointestinal bleed or major surgery within 3 months
  • Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
  • TIA or minor stroke induced by angiography or surgery
  • Severe noncardiovascular comorbidity with life expectancy <3 months
  • Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result
  • Severe renal failure, defined as Glomerular Filtration Rate (GFR) <30 ml/min -Severe hepatic insufficiency (Child-Pugh score B to C)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02221102

Layout table for location contacts
Contact: Xuedong Liu +86 029 84775055

Layout table for location information
China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Contact: Fang Yang, M.D. Ph.D.    +86 029 84773214   
Principal Investigator: Gang Zhao, M.D.         
Sponsors and Collaborators
Xijing Hospital
Layout table for investigator information
Study Chair: Gang Zhao, M.D. Xijing hostipal
Layout table for additonal information
Responsible Party: Xijing Hospital Identifier: NCT02221102    
Other Study ID Numbers: Xijing-Edoxaban
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Xijing Hospital:
new oral anticoagulant
acute minor ischemic stroke
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors