IschemiaPhase 2/3NCT02221102
Edoxaban for TIA and Acute Minor Stroke
A Phase 2/3 study testing Aspirin and edoxaban in people with Ischemia and Stroke, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemia, Stroke, Cerebral Infarction
- What is being tested?
- Aspirin and edoxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,700 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jun 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710032
Fang Yang, M.D. Ph.D., +86 029 84773214, fyangx@fmmu.edu.cn
Gang Zhao, M.D.
About this study
Official title: Treatment of Edoxaban Versus Aspirin for Non-disabling Cerebrovascular Events: Rationale, Objectives, and Design
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
- Being tested
- Aspirin, edoxaban, placebo
- Keywords
- edoxaban, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke
- Medical subject headings
- Ischemia, Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic acid
non-steroidal anti-inflammatory drugs
edoxabanDrug
Also called DU176b, LIXIANA TABLETS
orally active direct factor Xa inhibitor
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| aspirin | Active comparator | Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30 Receives: Drug: Aspirin; Drug: placebo |
| edoxaban 30mg | Experimental | Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30 Receives: Drug: edoxaban; Drug: placebo |
| edoxaban 60mg | Experimental | Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30 Receives: Drug: edoxaban; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with new stroke (ischemic or hemorrhage)
Measured: 90 days
Secondary outcomes (6)
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Measured: 30 days
mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6
Measured: 30 days and 90 days
Changes in NIHSS scores
Measured: 90 days
moderate to severe bleeding events
Measured: 90 days
Total mortality
Measured: 90 days
Adverse events/severe adverse events reported by the investigators
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, M.D., Study chair, Xijing hostipal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221102
- Sponsor's protocol ID
- Xijing-Edoxaban
- Status last verified
- Aug 2014
- First submitted
- 18 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Edoxaban Versus Aspirin for Non-disabling Cerebrovascular Events: Rationale, Objectives, and Design
- ClinicalTrials.gov ID
- NCT02221102
- Acronym / sponsor ID
- Xijing-Edoxaban
- Conditions
- Ischemia, Stroke, Cerebral Infarction
- Keywords
- edoxaban, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,700 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aspirin | Active comparator | Drug: Aspirin, Drug: placeboReceiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30 |
| edoxaban 30mg | Experimental | Drug: edoxaban, Drug: placeboReceiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30 |
| edoxaban 60mg | Experimental | Drug: edoxaban, Drug: placeboReceiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Acetylsalicylic acidnon-steroidal anti-inflammatory drugs | Drug | aspirin |
| edoxabanAlso: DU176b, LIXIANA TABLETSorally active direct factor Xa inhibitor | Drug | edoxaban 30mg, edoxaban 60mg |
| placebo | Drug | aspirin, edoxaban 30mg, edoxaban 60mg |
Primary outcome
percentage of patients with new stroke (ischemic or hemorrhage)
Time frame: 90 days
6 secondary outcomes
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time frame: 30 days
mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6
Time frame: 30 days and 90 days
Changes in NIHSS scores
Time frame: 90 days
moderate to severe bleeding events
Time frame: 90 days
Total mortality
Time frame: 90 days
Adverse events/severe adverse events reported by the investigators
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Zhao, M.D. study chair
Xijing hostipal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aspirin and edoxaban in people with Ischemia and Stroke, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuedong Liu (+86 029 84775055, liuxued@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with new stroke (ischemic or hemorrhage) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.