Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
NCT04078737 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6412
Last updated 2021-12-02
Summary
The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.
Conditions
- Stroke
- Transient Ischemic Attack
Interventions
- DRUG
-
Ticagrelor and Aspirin
Day of randomization: Day1:Ticagrelor 180mg; placebo of clopidogrel 300mg; aspirin 75-300mg (open label) Day2-21st: Ticagrelor 90mg bid/day; placebo of clopidogrel 75mg; aspirin 75mg (open label) Day 22nd-3 months:Ticagrelor 90mg bid/day; placebo of clopidogrel 75mg
- DRUG
-
Clopidogrel and Aspirin
Day of randomization: Day 1: Clopidogrel 300mg; placebo of ticagrelor 180mg; aspirin 75-300mg (open label) Day2-21st: Clopidogrel 75mg/day; placebo of ticagrelor 90mg bid/day; aspirin 75mg (open label) Day 22nd-3 months:Clopidogrel 75mg; placebo of ticagrelor 90mg bid/day
Sponsors & Collaborators
-
Ministry of Science and Technology of the People´s Republic of China
collaborator OTHER_GOV -
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Yongjun Wang, M.D · Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-23
- Primary Completion
- 2021-06-24
- Completion
- 2021-07-01
Countries
- China
Study Locations
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