This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention (PCI) will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
279
Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
Beijing Anzhen Hospital, Capital Medical Universily
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Inhibition of platelet aggregation
Inhibition of platelet aggregation will be assessed by Verifynow System
Time frame: 28 days after treatment
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Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 17 more locations