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This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).
This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | basic medication + Yangxinshi tablet |
|
| Control group | Other | basic medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yangxinshi tablet | Drug | In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 6MWD | The 6-min walking distance | 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Borg scale | score range: 0~10,higher scores mean a worse outcome. | 24 weeks after treatment |
| MACCE | incidence of major adverse cardiovascular and cerebrovascular events (MACCE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Haitao | Contact | 0531-68776356 | doctoryuanht@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Haitao | Shandong Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shapingba District People's Hospital of Chongqing | Not yet recruiting | Chongqing | Chongqing Municipality | China | ||
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|
| Basic medication | Other | The control group will be given basic medication only. The treatment period is 24 weeks. |
|
| after 4, 8, 12, 16, 20, and 24 weeks of treatment |
| Zhengzhou Seventh People's Hospital |
| Not yet recruiting |
| Zhengzhou |
| Henan |
| China |
| Binzhou Medical University Hospital | Not yet recruiting | Binzhou | Shandong | China |
| Binzhou People's Hospital | Not yet recruiting | Binzhou | Shandong | China |
| Dezhou Municiple Hospital | Not yet recruiting | Dezhou | Shandong | China |
| Pingyuan County first People's Hospital | Not yet recruiting | Dezhou | Shandong | China |
| Feicheng People's Hospital | Recruiting | Feicheng | Shandong | China |
| Shandong Health Group Feicheng Hospital | Recruiting | Feicheng | Shandong | China |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Recruiting | Jinan | Shandong | China |
|
| Jinan Central Hospital | Not yet recruiting | Jinan | Shandong | China |
| Jinan Zhangqiu District People's Hospital | Not yet recruiting | Jinan | Shandong | China |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | China |
|
| The Fourth People's Hospital of Jinan | Not yet recruiting | Jinan | Shandong | China |
| Gaotang County People's Hospital | Not yet recruiting | Liaocheng | Shandong | China |
| Liaocheng Hospital of Traditional Chinese Medicine | Not yet recruiting | Liaocheng | Shandong | China |
| Liaocheng People's Hospital | Not yet recruiting | Liaocheng | Shandong | China |
| The Second People's Hospital of Liaocheng | Not yet recruiting | Liaocheng | Shandong | China |
| Linqing City People's Hospital | Not yet recruiting | Linqing | Shandong | China |
| Linyi People's Hospital | Not yet recruiting | Linyi | Shandong | China |
| Longkou People Hosptial | Not yet recruiting | Longkou | Shandong | China |
| Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
| Hospital of Cardiovascular Diseases Affiliated to Qingdao University | Recruiting | Qingdao | Shandong | China |
| Qingdao Central Hospital | Not yet recruiting | Qingdao | Shandong | China |
| Qingdao Fuwai Hospital | Not yet recruiting | Qingdao | Shandong | China |
| Qingdao Municipal Hospital | Not yet recruiting | Qingdao | Shandong | China |
| Shandong University Qilu Hospital Qingdao District | Not yet recruiting | Qingdao | Shandong | China |
| The Second Affiliated Hospital of Shandong First Medical University | Not yet recruiting | Taian | Shandong | China |
| Xintai People's Hospital | Not yet recruiting | Taian | Shandong | China |
| Tengzhou Central People's Hospital | Not yet recruiting | Tengzhou | Shandong | China |
| Weifang City People's Hospital | Not yet recruiting | Weifang | Shandong | China |
| Weifang City Yidu Central Hospital | Not yet recruiting | Weifang | Shandong | China |
| Yantai Hospital of Traditional Chinese Medicine | Not yet recruiting | Yantai | Shandong | China |
| ID | Term |
|---|---|
| C000628007 | Yangxinshi |
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