Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events
NCT ID: NCT00979589
Last Updated: 2020-07-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
5100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-12-31
Study Completion Date
2012-06-30
Brief Summary
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The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.
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Detailed Description
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Inclusion criteria:
1. Adult subjects (male or female ≥ 40 years)
2. Acute non-disabling 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.
3. TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score ≥ 4 at the time of randomization). Symptom onset is defined by the "last see normal" principle.
4. Informed consent signed
Primary Efficacy Endpoint:
Percentage of patients with the 3-month new vascular events, defined as any event of the following:Any stroke (ischemic or hemorrhage).
1. Adult subjects (male or female ≥ 40 years)
2. Acute non-disabling 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.
3. TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score ≥ 4 at the time of randomization). Symptom onset is defined by the "last see normal" principle.
4. Informed consent signed
Primary Efficacy Endpoint:
Percentage of patients with the 3-month new vascular events, defined as any event of the following:Any stroke (ischemic or hemorrhage).
Conditions
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Stroke
Transient Ischemic Attack
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Combination Clopidogrel and asprin
Group Type
ACTIVE_COMPARATOR
Clopidogrel
Intervention Type
DRUG
The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.
Asprin and placebo
Group Type
PLACEBO_COMPARATOR
Placebo of clopidogrel and Asprin
Intervention Type
DRUG
The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.
Interventions
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Clopidogrel
The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.
Intervention Type
DRUG
Placebo of clopidogrel and Asprin
The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.
Intervention Type
DRUG
Other Intervention Names
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Plavix
Acetylsalicylic acid
Eligibility Criteria
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Inclusion Criteria
* Adult subjects (male or female≥40 years)
* Acute non-disabling 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 (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score≥4 at the time of randomization).Symptom onset is defined by the "last see normal" principle
* Informed consent signed
* Acute non-disabling 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 (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score≥4 at the time of randomization).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 non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI
* Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
* Modified Rankin Scale Score\>2 at randomization (pre-morbid historical assessment)
* NIH Stroke Score≥4 at randomization
* Clear indication for anticoagulation(presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
* Contraindication to clopidogrel or ASA
* Known allergy
* Severe renal or hepatic insufficiency
* Severe cardiac failure, asthma
* Hemostatic disorder or systemic bleeding
* History of hemostatic disorder or systemic bleeding
* History of thrombocytopenia or neutropenia
* History of drug-induced hematologic or hepatic abnormalities
* Low white blood cell (\<2 x109/l) or platelet count (\<100 x109/l)
* Use of thrombolysis within 24 hours prior to randomization
* History of intracranial hemorrhage
* Anticipated requirement for long-term non-study antiplatelet drugs, or NSAIDs affecting platelet function
* Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
* Gastrointestinal bleed or major surgery within 3 months
* Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
* Scheduled for surgery or interventional treatment requiring study drug cessation
* Qualifying TIA or minor stroke induced by angiography or surgery
* Severe non-cardiovascular comorbidity with life expectancy \< 3 months
* Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test
* Currently receiving an investigational drug or device
* Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
* Modified Rankin Scale Score\>2 at randomization (pre-morbid historical assessment)
* NIH Stroke Score≥4 at randomization
* Clear indication for anticoagulation(presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
* Contraindication to clopidogrel or ASA
* Known allergy
* Severe renal or hepatic insufficiency
* Severe cardiac failure, asthma
* Hemostatic disorder or systemic bleeding
* History of hemostatic disorder or systemic bleeding
* History of thrombocytopenia or neutropenia
* History of drug-induced hematologic or hepatic abnormalities
* Low white blood cell (\<2 x109/l) or platelet count (\<100 x109/l)
* Use of thrombolysis within 24 hours prior to randomization
* History of intracranial hemorrhage
* Anticipated requirement for long-term non-study antiplatelet drugs, or NSAIDs affecting platelet function
* Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
* Gastrointestinal bleed or major surgery within 3 months
* Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
* Scheduled for surgery or interventional treatment requiring study drug cessation
* Qualifying TIA or minor stroke induced by angiography or surgery
* Severe non-cardiovascular comorbidity with life expectancy \< 3 months
* Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test
* Currently receiving an investigational drug or device
Minimum Eligible Age
40 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of California, San Francisco
OTHER
Sponsor Role
collaborator
Beijing Tiantan Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Yongjun Wang
Executive Vice-President
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Yongjun NA Wang, M.D
Role: PRINCIPAL_INVESTIGATOR
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
S.Claiborne NA Johnston, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Departments of Neurology, Epidemiology, University of California, San Francisco, USA
Locations
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Beijing Tian Tan Hospital, Capital Medical University
Beijing, , China
Site Status
Countries
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China
References
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Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.
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BACKGROUND
Wang Y, Zhao X, Lin J, Li H, Johnston SC, Lin Y, Pan Y, Liu L, Wang D, Wang C, Meng X, Xu J, Wang Y; CHANCE investigators. Association Between CYP2C19 Loss-of-Function Allele Status and Efficacy of Clopidogrel for Risk Reduction Among Patients With Minor Stroke or Transient Ischemic Attack. JAMA. 2016 Jul 5;316(1):70-8. doi: 10.1001/jama.2016.8662.
Reference Type
BACKGROUND
Jing J, Meng X, Zhao X, Liu L, Wang A, Pan Y, Li H, Wang D, Johnston SC, Wang Y, Wang Y. Dual Antiplatelet Therapy in Transient Ischemic Attack and Minor Stroke With Different Infarction Patterns: Subgroup Analysis of the CHANCE Randomized Clinical Trial. JAMA Neurol. 2018 Jun 1;75(6):711-719. doi: 10.1001/jamaneurol.2018.0247.
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BACKGROUND
Pan Y, Elm JJ, Li H, Easton JD, Wang Y, Farrant M, Meng X, Kim AS, Zhao X, Meurer WJ, Liu L, Dietrich D, Wang Y, Johnston SC. Outcomes Associated With Clopidogrel-Aspirin Use in Minor Stroke or Transient Ischemic Attack: A Pooled Analysis of Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events (CHANCE) and Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trials. JAMA Neurol. 2019 Dec 1;76(12):1466-1473. doi: 10.1001/jamaneurol.2019.2531.
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BACKGROUND
Pan Y, Meng X, Jing J, Li H, Zhao X, Liu L, Wang D, Johnston SC, Wang Y, Wang Y; CHANCE Investigators. Association of multiple infarctions and ICAS with outcomes of minor stroke and TIA. Neurology. 2017 Mar 14;88(11):1081-1088. doi: 10.1212/WNL.0000000000003719. Epub 2017 Feb 15.
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Pan Y, Jing J, Chen W, Meng X, Li H, Zhao X, Liu L, Wang D, Johnston SC, Wang Y, Wang Y; CHANCE investigators. Risks and benefits of clopidogrel-aspirin in minor stroke or TIA: Time course analysis of CHANCE. Neurology. 2017 May 16;88(20):1906-1911. doi: 10.1212/WNL.0000000000003941. Epub 2017 Apr 19.
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Li J, Wang A, Zhao X, Liu L, Meng X, Lin J, Jing J, Zou X, Wang Y, Wang Y; CHANCE Investigators. High-sensitive C-reactive protein and dual antiplatelet in intracranial arterial stenosis. Neurology. 2018 Feb 6;90(6):e447-e454. doi: 10.1212/WNL.0000000000004928. Epub 2018 Jan 12.
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Han C, Yang M, Pan Y, Li H, Liu L, Meng X, Wang Y, Wang Y. Disabling Neurologic Deficits and Antiplatelet Therapy in Acute Minor Stroke. J Am Heart Assoc. 2025 Apr 15;14(8):e029734. doi: 10.1161/JAHA.122.029734. Epub 2025 Apr 7.
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DERIVED
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Yang M, Xu J, Xue J, Pan Y, Cheng A, Gao F, Meng X, Miao Z, Wang Y, Wang Y; CHANCE Investigators. Efficacy of dual antiplatelet therapy after ischemic stroke according to hsCRP levels and CYP2C19 genotype. Am Heart J. 2025 Feb;280:89-97. doi: 10.1016/j.ahj.2024.10.017. Epub 2024 Nov 12.
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Qiu X, Zhang Y, Gu H, Jiang Y, Pan Y, Jiang Y, Meng X, Wang Y, Zhao X, Li H, Wang X, Wang Y, Li Z; CHANCE Investigators. Association Between CYP2B6 Polymorphisms and Efficacy of Clopidogrel in Minor Stroke or Transient Ischemic Attack. Stroke. 2023 Jul;54(7):1770-1776. doi: 10.1161/STROKEAHA.122.040507. Epub 2023 Jun 2.
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Chen P, Wu Q, Xie X, Jing J, Gu H, Wang X, Meng X, Liu L, Wang Y, Wang Y; CHANCE Investigators. Systolic blood pressure and recurrent stroke in patients with different lesion patterns on diffusion weighted imaging. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1350-1357. doi: 10.1111/jch.14543. Epub 2022 Aug 12.
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Li J, Zhao X, Meng X, Lin J, Liu L, Wang C, Wang A, Wang Y, Wang Y; CHANCE Investigators. High-Sensitive C-Reactive Protein Predicts Recurrent Stroke and Poor Functional Outcome: Subanalysis of the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events Trial. Stroke. 2016 Aug;47(8):2025-30. doi: 10.1161/STROKEAHA.116.012901. Epub 2016 Jun 21.
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Li Z, Wang Y, Zhao X, Liu L, Wang D, Wang C, Meng X, Li H, Pan Y, Wang X, Wang C, Yang X, Zhang C, Jing J, Xian Y, Johnston SC, Wang Y; CHANCE Investigators. Treatment Effect of Clopidogrel Plus Aspirin Within 12 Hours of Acute Minor Stroke or Transient Ischemic Attack. J Am Heart Assoc. 2016 Mar 21;5(3):e003038. doi: 10.1161/JAHA.115.003038.
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Liu L, Wong KS, Leng X, Pu Y, Wang Y, Jing J, Zou X, Pan Y, Wang A, Meng X, Wang C, Zhao X, Soo Y, Johnston SC, Wang Y; CHANCE Investigators. Dual antiplatelet therapy in stroke and ICAS: Subgroup analysis of CHANCE. Neurology. 2015 Sep 29;85(13):1154-62. doi: 10.1212/WNL.0000000000001972.
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Li J, Wang Y, Lin J, Wang D, Wang A, Zhao X, Liu L, Wang C, Wang Y; CHANCE Investigators. Soluble CD40L Is a Useful Marker to Predict Future Strokes in Patients With Minor Stroke and Transient Ischemic Attack. Stroke. 2015 Jul;46(7):1990-2. doi: 10.1161/STROKEAHA.115.008685. Epub 2015 May 26.
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Wang Y, Pan Y, Zhao X, Li H, Wang D, Johnston SC, Liu L, Meng X, Wang A, Wang C, Wang Y; CHANCE Investigators. Clopidogrel With Aspirin in Acute Minor Stroke or Transient Ischemic Attack (CHANCE) Trial: One-Year Outcomes. Circulation. 2015 Jul 7;132(1):40-6. doi: 10.1161/CIRCULATIONAHA.114.014791. Epub 2015 May 8.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008ZX09312-008
Identifier Type: -
Identifier Source: org_study_id
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