Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (CHANCE)
|ClinicalTrials.gov Identifier: NCT00979589|
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : March 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stroke Transient Ischemic Attack||Drug: Clopidogrel Drug: Placebo of clopidogrel and Asprin||Phase 3|
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||July 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
|Active Comparator: Combination Clopidogrel and asprin||
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
|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 Name: Acetylsalicylic acid
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979589
|Beijing Tian Tan Hospital, Capital Medical University|
|Beijing, China, 100050|
|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|