Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Ischemic Stroke TIA |
Intervention | Drug: Apixaban Drug: Clopidogrel Drug: Aspirin Drug: placebo |
Phase | Phase 2/Phase 3 |
Sponsor | Xijing Hospital |
Responsible Party | Xijing Hospital |
ClinicalTrials.gov Identifier | NCT01924325 |
First Received | August 13, 2013 |
Last Updated | August 13, 2013 |
Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | August 13, 2013 |
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Last Updated Date | August 13, 2013 |
Start Date | January 2014 |
Estimated Primary Completion Date | July 2016 |
Current Primary Outcome Measures | percentage of patients with new stroke (ischemic or hemorrhage) [Time Frame: 90 days] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events |
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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 |
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. |
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 Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Apixaban orally active direct factor Xa inhibitor Other Names:
an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor Other Names:
a non-steroidal anti-inflammatory drug Other Names: Acetylsalicylic acidDrug: placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 10000 |
Estimated Completion Date | July 2016 |
Estimated Primary Completion Date | December 2015 |
Eligibility Criteria | 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) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Xuedong Liu, M.D. +86 029 84775055 liuxued@fmmu.edu.cn |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01924325 |
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Other Study ID Numbers | Xijing-ADANCE |
Has Data Monitoring Committee | Yes |
Information Provided By | Xijing Hospital |
Study Sponsor | Xijing Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Gang Zhao, M.D. Neurology Department,Xijing Hospital |
Verification Date | August 2013 |
Locations[ + expand ][ + ]
Xijing Hospital | Xi'an, Shaanxi, China, 710032 Contact: Fang Yang, M.D. Ph.D. | +86 029 84773214 | fyangx@fmmu.edu.cnPrincipal Investigator: Gang Zhao, M.D. Not yet recruiting |
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