Edoxaban for TIA and Acute Minor Stroke

NCT02221102 | Unknown Phase 2 DMC

• 1 other identifier: Xijing-Edoxaban
• Study Type: interventional
• Target: 3,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Stroke; Cerebral Infarction

Keywords

edoxaban; aspirin; new oral anticoagulant; TIA; acute minor ischemic stroke

Outcome Measures

Primary Outcomes (1)

• percentage of patients with new stroke (ischemic or hemorrhage)

  90 days

Secondary Outcomes (6)

• Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)

  30 days

• mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6

  30 days and 90 days

• Changes in NIHSS scores

  90 days

• moderate to severe bleeding events

  90 days

• Total mortality

  90 days

Study Arms (3)

aspirin

ACTIVE COMPARATOR

Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30

Drug: Aspirin; Drug: placebo

edoxaban 30mg

EXPERIMENTAL

Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30

Drug: edoxaban; Drug: placebo

edoxaban 60mg

EXPERIMENTAL

Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30

Drug: edoxaban; Drug: placebo

Interventions

Aspirin DRUG

non-steroidal anti-inflammatory drugs

Also known as: Acetylsalicylic acid

aspirin

edoxaban DRUG

orally active direct factor Xa inhibitor

Also known as: DU176b, LIXIANA TABLETS

edoxaban 30mg; edoxaban 60mg

placebo DRUG

aspirin; edoxaban 30mg; edoxaban 60mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Ischemia; Stroke; Cerebral Infarction

Interventions

Aspirin; edoxaban

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gang Zhao, M.D.

  Xijing hostipal

  STUDY CHAIR

Central Study Contacts

Xuedong Liu

CONTACT

+86 029 84775055; liuxued@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

CN (1)