A Phase 3 interventional study of Clopidogrel and Placebo of clopidogrel and Asprin in Stroke and Transient Ischemic Attack, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Beijing Tiantan Hospital · Phase 3, Interventional, and Prevention
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.
Inclusion criteria:
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).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 5,100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Clopidogrel
Drug: Placebo of 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.
Also known as: Plavix
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.
Also known as: 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
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital