Ischemic StrokePhase 2/3ADANCENCT01924325
Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events
A Phase 2/3 study testing Apixaban, Clopidogrel and Aspirin in people with Ischemic Stroke and TIA, run by Xijing Hospital at 1 site in China.
Trial summary
Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, TIA
- What is being tested?
- Apixaban, Clopidogrel and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jul 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
- History of intracranial hemorrhage
Show all 13Show fewer
- 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: Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in High-risk Patients With Acute Non-disabling Cerebrovascular Events (ADANCE): Rationale, Objectives, and Design
Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants with less risk of bleeding events.
To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized, double-blind, multicenter, controlled clinical trial has been designed. The investigators will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling cerebrovascular event.
Read the detailed description
The ADANCE study is a randomized, double-blind clinical trial with a target enrollment of 3,000 Chinese patients. Two subtypes of patients will be enrolled: I, acute disabling ischemic stroke (<24 hours of symptoms onset); II, acute TIA (<24 hours of symptoms onset).
Patients will be randomized into 3 groups:
Ⅰ Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily.
Ⅱ Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21.
Ⅲ Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21.
From day 22 to 3 months, all patients will receive 75-mg dose of clopidogrel long-term antiplatelet therapy.
The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days.
- Conditions
- Ischemic Stroke, TIA
- Being tested
- Apixaban, Clopidogrel, Aspirin, placebo
- Keywords
- apixaban, clopidogrel, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis, BMS-562247, BMS-562247-01
orally active direct factor Xa inhibitor
ClopidogrelDrug
Also called Plavix, Clopivid
an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor
AspirinDrug
Also called Acetylsalicylic acid
a non-steroidal anti-inflammatory drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dual-antiplatelet Therapy | Active comparator | Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: placebo |
| Apixaban 2.5mg | Experimental | Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21 Receives: Drug: Apixaban; Drug: placebo |
| Apixaban 5mg | Experimental | Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21 Receives: Drug: Apixaban; 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
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
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 posted16 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, M.D., Principal investigator, Neurology Department,Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924325
- Sponsor's protocol ID
- Xijing-ADANCE
- Acronym
- ADANCE
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in High-risk Patients With Acute Non-disabling Cerebrovascular Events (ADANCE): Rationale, Objectives, and Design
- ClinicalTrials.gov ID
- NCT01924325
- Acronym / sponsor ID
- ADANCE / Xijing-ADANCE
- Conditions
- Ischemic Stroke, TIA
- Keywords
- apixaban, clopidogrel, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 16 Aug 2013 (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.
Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants with less risk of bleeding events.
To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized, double-blind, multicenter, controlled clinical trial has been designed. The investigators will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling cerebrovascular event.
Detailed description
The ADANCE study is a randomized, double-blind clinical trial with a target enrollment of 3,000 Chinese patients. Two subtypes of patients will be enrolled: I, acute disabling ischemic stroke (<24 hours of symptoms onset); II, acute TIA (<24 hours of symptoms onset).
Patients will be randomized into 3 groups:
Ⅰ Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily.
Ⅱ Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21.
Ⅲ Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21.
From day 22 to 3 months, all patients will receive 75-mg dose of clopidogrel long-term antiplatelet therapy.
The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days.
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 |
|---|---|---|
| Dual-antiplatelet Therapy | Active comparator | Drug: Clopidogrel, Drug: Aspirin, Drug: placeboReceiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily |
| Apixaban 2.5mg | Experimental | Drug: Apixaban, Drug: placeboReceiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21 |
| Apixaban 5mg | Experimental | Drug: Apixaban, Drug: placeboReceiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21 |
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 (13 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
- Thrombolysis for ischemic stroke within preceding 7 days
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 |
|---|---|---|
| ApixabanAlso: Eliquis, BMS-562247, BMS-562247-01orally active direct factor Xa inhibitor | Drug | Apixaban 2.5mg, Apixaban 5mg |
| ClopidogrelAlso: Plavix, Clopividan irreversible inhibitor of the P2Y12 adenosine diphosphate receptor | Drug | Dual-antiplatelet Therapy |
| AspirinAlso: Acetylsalicylic acida non-steroidal anti-inflammatory drug | Drug | Dual-antiplatelet Therapy |
| placebo | Drug | Apixaban 2.5mg, Apixaban 5mg, Dual-antiplatelet Therapy |
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
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
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 16 Aug 2013.
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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. principal investigator
Neurology Department,Xijing Hospital
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 Apixaban, Clopidogrel and Aspirin in people with Ischemic Stroke and TIA, 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 13 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 16 Aug 2013. 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, M.D. (+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 16 Aug 2013.