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History of Changes for Study: NCT00979589
Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (CHANCE)
Latest version (submitted July 13, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 17, 2009 None (earliest Version on record)
2 October 13, 2009 Arms and Interventions, Study Status, References, Study Design, Study Description, Contacts/Locations, Eligibility, Outcome Measures, Conditions, Oversight and Study Identification
3 January 19, 2010 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Description
4 January 20, 2010 Study Status and Study Identification
5 April 15, 2010 Contacts/Locations and Study Status
6 March 11, 2012 Recruitment Status, Sponsor/Collaborators, Study Status, Contacts/Locations, References and Study Design
7 July 13, 2020 Sponsor/Collaborators, Study Status, References and Study Identification
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Study NCT00979589
Submitted Date:  March 11, 2012 (v6)

Open or close this module Study Identification
Unique Protocol ID: 2008ZX09312-008
Brief Title: Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2012
Overall Status: Completed
Study Start: July 2008
Primary Completion: March 2012 [Actual]
Study Completion: March 2012 [Actual]
First Submitted: September 17, 2009
First Submitted that
Met QC Criteria:
September 17, 2009
First Posted: September 18, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 11, 2012
Last Update Posted: March 13, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: yongjun wang
Responsible Party: Sponsor-Investigator
Investigator: Yongjun Wang
Official Title: Vice president of Beijing Tiantan Hospital
Affiliation: Ministry of Science and Technology of the People´s Republic of China
Collaborators: University of California, San Francisco
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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:

  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).

Open or close this module Conditions
Conditions: 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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 5100 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Combination Clopidogrel and asprin Drug: 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.
Other Names:
  • Plavix
Placebo Comparator: Asprin and placebo 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.
Other Names:
  • Acetylsalicylic acid
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 Measures:
2. 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]
3. 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]
4. Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up).

[Time Frame: 3 months]
5. Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale)

[Time Frame: 3 months]
6. 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]
7. Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.

[Time Frame: 3 months]
8. Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months

[Time Frame: 3 months]
9. Intracranial hemorrhage

[Time Frame: 3 months]
10. Total mortality

[Time Frame: 3 months]
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Yongjun NA Wang, M.D
Principal Investigator
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
S.Claiborne NA Johnston, M.D, Ph.D
Principal Investigator
Departments of Neurology, Epidemiology, University of California, San Francisco, USA
Locations: China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, China, 100050
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: [Study Results] 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. PubMed 20826243
Links: Description: Tiantan clinical trial and research center for stroke
Available IPD/Information:

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