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Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (CHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00979589
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Yongjun Wang, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE September 17, 2009
First Posted Date  ICMJE September 18, 2009
Last Update Posted Date July 15, 2020
Study Start Date  ICMJE December 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2009)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
  • 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 ]
  • 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 ]
  • Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up). [ Time Frame: 3 months ]
  • Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale) [ Time Frame: 3 months ]
  • 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 ]
  • Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. [ Time Frame: 3 months ]
  • Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months [ Time Frame: 3 months ]
  • Intracranial hemorrhage [ Time Frame: 3 months ]
  • Total mortality [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2009)
  • 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 ]
  • 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 ]
  • Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up). [ Time Frame: 3 months ]
  • Further efficacy exploratory analysis:Cognitive function (changes in Digit-Symbol Substitution Test [DSST] score will be calculated between baseline and at 3 month visit). [ Time Frame: 3 months ]
  • Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale) [ Time Frame: 3 months ]
  • 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 ]
  • Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. [ Time Frame: 3 months ]
  • Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months [ Time Frame: 3 months ]
  • Intracranial hemorrhage [ Time Frame: 3 months ]
  • Total mortality [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke
  • Transient Ischemic Attack
Intervention  ICMJE
  • 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 Name: Plavix
  • 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 Name: Acetylsalicylic acid
Study Arms  ICMJE
  • Active Comparator: Combination Clopidogrel and asprin
    Intervention: Drug: Clopidogrel
  • Placebo Comparator: Asprin and placebo
    Intervention: Drug: Placebo of clopidogrel and Asprin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2009)		 5100
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2009)		 5200
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00979589
Other Study ID Numbers  ICMJE 2008ZX09312-008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yongjun Wang, Beijing Tiantan Hospital
Original Responsible Party Yongjun Wang, Beijing Tian Tan Hospital, Capital Medical University, China
Current Study Sponsor  ICMJE Beijing Tiantan Hospital
Original Study Sponsor  ICMJE Ministry of Science and Technology of the People´s Republic of China
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Yongjun NA Wang, M.D Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Principal Investigator: S.Claiborne NA Johnston, M.D, Ph.D Departments of Neurology, Epidemiology, University of California, San Francisco, USA
PRS Account Beijing Tiantan Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP