Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events
ADANCE
1 other identifier
interventional
10,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 16, 2013
August 1, 2013
1.9 years
August 13, 2013
August 13, 2013
Conditions
Keywords
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
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
30 days and 90 days
Changes in NIHSS scores
90 days
moderate to severe bleeding events
90 days
Total mortality
90 days
- +1 more secondary outcomes
Study Arms (3)
Dual-antiplatelet Therapy
ACTIVE COMPARATORReceiving 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
EXPERIMENTALReceiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21
Apixaban 5mg
EXPERIMENTALReceiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21
Interventions
orally active direct factor Xa inhibitor
an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor
a non-steroidal anti-inflammatory drug
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Zhao, M.D.
Neurology Department,Xijing Hospital
Central Study Contacts
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 13, 2013
First Posted
August 16, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
August 16, 2013
Record last verified: 2013-08