Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017YFC1700503 | Other Grant/Funding Number | National Key R&D Program-Research ; Modernization of TCM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year |
|
| Control group | Placebo Comparator | First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongxinluo | Drug | tid, po. |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | 30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke) | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Revascularization | Incidence of revascularization of the primary endpoints | 30-day |
| Cerebral stroke | Incidence of cerebral stroke of the primary endpoints |
| Measure | Description | Time Frame |
|---|---|---|
| Total white cell count | Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. | 7 days, 1 month, 6 months and 1 year after medication |
| Red blood cell |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang-Dong Li, MD | Contact | 13263138665 | fuwai_lxd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yue-Jin Yang, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37874574 | Derived | Yang Y, Li X, Chen G, Xian Y, Zhang H, Wu Y, Yang Y, Wu J, Wang C, He S, Wang Z, Wang Y, Wang Z, Liu H, Wang X, Zhang M, Zhang J, Li J, An T, Guan H, Li L, Shang M, Yao C, Han Y, Zhang B, Gao R, Peterson ED; CTS-AMI Investigators. Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1534-1545. doi: 10.1001/jama.2023.19524. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C513941 | tongxinluo |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
tid, po. |
|
| 30-day |
| STEMI | 30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias. | 30-day |
| The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V | The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V at 30-day between 0-30%. | 30-day |
| MACCE | 1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event. | 1 year |
| In-stent restenosis | 1-year incidence of In-stent restenosis | 1 year |
| All-cause mortality rate at 1 year | Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year. | 1 year |
| Myocardial reperfusion and no-reflow | Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy. | 2 hours, 24 hours and 7 days |
Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
| 7 days, 1 month, 6 months and 1 year after medication |
| Hemoglobin | Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. | 7 days, 1 month, 6 months and 1 year after medication |
| Blood platelet count | Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. | 7 days, 1 month, 6 months and 1 year after medication |
| Beijing Aerospace General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100076 | China |
|
| Beijing Renhe Hospital | Recruiting | Beijing | Beijing Municipality | 102600 | China |
|
| Harrison International Peace Hospital | Not yet recruiting | Hengshui | Hebei | 053000 | China |
|
| Henan Provincial Peoples Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
|
| Taian City Central Hospital | Not yet recruiting | Tai’an | Shandong | 271000 | China |
|
| First Teaching Hospital of Tianjin University of TCM | Not yet recruiting | Tianjin | Tianjin Municipality | 300193 | China |
|