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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 | Experimental | Experimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days |
|
| Experimental group 2 | Experimental | Experimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days |
|
| Experimental group 3 | Experimental | Experimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days |
|
| Control group | Active Comparator | Control group: Clopidogrel 300mg loading followed by 75mg/day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicagrel 5mg | Drug | Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of platelet aggregation | Inhibition of platelet aggregation will be assessed by Verifynow System | 28 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital Bengbu Medical College | Bengbu | Anhui | 233004 | China | ||
| Beijing Anzhen Hospital, Capital Medical Universily |
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| Vicagrel 6mg | Drug | Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days |
|
| Vicagrel 7.5mg | Drug | Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days |
|
| Clopidogrel 75mg | Drug | Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days |
|
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510030 | China |
| First Affiliated Hospital of Zhongshan University | Guangzhou | Guangdong | 510080 | China |
| First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050100 | China |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | 430022 | China |
| Changsha Central Hospital | Changsha | Hunan | 410004 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| Affiliated Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital of Southeast University | Nanjing | Jiangsu | 210009 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Second Hospital of Jilin University | Changchun | Jinin | 130041 | China |
| the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army(The General Hospital of Shenyang Military) | Shenyang | Liaoning | 110015 | China |
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | 110015 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110134 | China |
| Qinghai Provincial People's Hospital | Xining | Qinghai | 810007 | China |
| Yuncheng Central Hospital | Yuncheng | Shanxi | 044000 | China |
| Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | 646000 | China |
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310020 | China |
| China-Japan Friendship Hospital | Beijing | 100029 | China |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| Tianjin People's Hospital | Tianjin | 300121 | China |
| Tianjin Medical University General Hospital | Tianjing | 300052 | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C574646 | methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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