Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (CHANCE)
Primary Purpose
Stroke, Transient Ischemic Attack
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Clopidogrel
Placebo of clopidogrel and Asprin
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring stroke, transient ischemic attack, acute treatment, acute non-disabling cerebrovascular event, clopidogrel, clopidogrel combined with ASA, recurrence of stroke and other vascular events
Eligibility Criteria
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
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
Sites / Locations
- Beijing Tian Tan Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Combination Clopidogrel and asprin
Asprin and placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
Secondary Outcome Measures
Percentage of patients with the 3-month new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually.
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3 month follow-up
Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up).
Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale)
Efficacy endpoint will also be analyzed stratified by etiological subtypes, by time randomization (< 12 hours vs. ≥ 12 hours), by qualifying event (TIA vs. minor stroke), and by age
Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months
Intracranial hemorrhage
Total mortality
Full Information
NCT ID
NCT00979589
First Posted
September 17, 2009
Last Updated
July 13, 2020
Sponsor
Beijing Tiantan Hospital
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00979589
Brief Title
Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events
Acronym
CHANCE
Official Title
Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
stroke, transient ischemic attack, acute treatment, acute non-disabling cerebrovascular event, clopidogrel, clopidogrel combined with ASA, recurrence of stroke and other vascular events
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination Clopidogrel and asprin
Arm Type
Active Comparator
Arm Title
Asprin and placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
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
Intervention Name(s)
Placebo of clopidogrel and Asprin
Other Intervention Name(s)
Acetylsalicylic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage of patients with the 3-month new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually.
Time Frame
3 months
Title
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3 month follow-up
Time Frame
3 months
Title
Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up).
Time Frame
3 months
Title
Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale)
Time Frame
3 months
Title
Efficacy endpoint will also be analyzed stratified by etiological subtypes, by time randomization (< 12 hours vs. ≥ 12 hours), by qualifying event (TIA vs. minor stroke), and by age
Time Frame
3 months
Title
Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
Time Frame
3 months
Title
Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months
Time Frame
3 months
Title
Intracranial hemorrhage
Time Frame
3 months
Title
Total mortality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun NA Wang, M.D
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S.Claiborne NA Johnston, M.D, Ph.D
Organizational Affiliation
Departments of Neurology, Epidemiology, University of California, San Francisco, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Citations:
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20826243
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26012640
Citation
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.
Results Reference
derived
PubMed Identifier
25957224
Citation
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.
Results Reference
derived
Learn more about this trial
Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events
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