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| Name | Class |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
| General Hospital of Beijing PLA Military Region | OTHER |
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To evaluate the therapeutic evaluation of combination therapy with aspirin and salvianolate injection based on the population pharmacokinetics and TEG.A prospective, multicenter, randomized, controlled clinical trial is used.A total of 120 patients will be recruited and will be divided into three groups,respectively salvianolate injection group,aspirin group and salvianolate injection and aspirin group，and the course of treatment is 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salvianolate injection group | Other | Salvianolate injection,intravenously infusion,0.2g/time,once a day;other routine treatment according to the condition of the disease |
|
| Aspirin group | Active Comparator | Aspirin,oral administration method,0.1g/time,once a day;other routine treatment according to the condition of the disease |
|
| Salvianolate injection and aspirin group | Experimental | Salvianolate injection,intravenously infusion,0.2g/time,once a day;aspirin,oral administration method,0.1g/time,once a day;other routine treatment according to the condition of the disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salvianolate injection | Drug | Traditional Chinese medicine injection，a kind of innovative drugs developed by Shanghai institute of materia medica, Chinese academy of sciences after 13 years of research and development.the content of magnesium acetate was 80%, and the other 20% were magnesium acetate.It has the function of promoting blood circulation,removing blood stasis and blood stasis,and is used for treating coronary heart disease with stable angina pectoris. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of thromboela-stogram（R time,K time,α angle,MA、CI、TPI） | Thromboela-stogram(TEG) Is a reflection of the dynamic changes in blood coagulation (including the formation rate of fibrin, the dissolution of the state and the consistency of the solid, elastic degree) of the index: R time is the latency of the first fibrin plaque formation. K time is to assess the rate at which blood clots reach a certain level. The alpha angle is similar to the K time, but is more comprehensive than the K time, and is not affected by the low coagulation state. MA reflects the maximum amplitude of blood clots. CI is an integrated coagulation index.TPI is the index of platelet kinetics | Change from base line on the tenth day |
| Measure | Description | Time Frame |
|---|---|---|
| Change of symptom score of the Seattle Angina Questionnaiire(SAQ) | SAQ includes 5 dimensions: the degree of physical activity limitation, the stable state of angina pectoris, the frequency of angina attack, the degree of treatment satisfaction, and the recognition of the disease | Change from base line on the tenth day |
| Measure | Description | Time Frame |
|---|---|---|
| Change of PT | An index to reflect the status of the extrinsic coagulation system | Change from base line on the tenth day |
| Adverse events | Change from base line on the tenth day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianxin Wang, doctor | Contact | 86-13521781839 | wanglianxin_tcm@126.com | |
| Junjie Jiang, doctor | Contact | 86-18910206360 | studentjiangjunjie@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanming Xie, Study Chair | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100091 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33360345 | Derived | Lyu J, Xue M, Li J, Lyu W, Wen Z, Yao P, Li J, Zhang Y, Gong Y, Xie Y, Chen K, Wang L, Chai Y. Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial. Phytomedicine. 2021 Jan;81:153419. doi: 10.1016/j.phymed.2020.153419. Epub 2020 Dec 10. |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C561960 | salvianolate |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
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|
| Aspirin | Drug | Molecular chemical formula: C9H8O4,molecular structure type: CH3COOC6H4COOH. It has the role of anti thrombosis In vivo, and it can inhibit the release of the platelet reaction, inhibit platelet aggregation, which is related to the reduction of TXA2 generation. Clinically itused to prevent the onset of cardiovascular and cerebrovascular diseases. |
|
| Change of ECG abnormalities |
ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris |
| Change from base line on the tenth day |
| Change of score of Traditional Chinese Medicine(TCM) symptom curative effect rating scale | It includes the description of scores of symptoms, signs of tongue and pulse related to blood stasis syndrome of diagnosis of traditional Chinese medicine | Change from base line on the tenth day |
| Change of platelet aggregation measured by light transmittance aggregometry(LTA) | The method is widely recognized, and is even considered a gold standard | Change from base line on the tenth day |
| Change of serum lipids（TC、TG、HDL-C、LDL-C） | Hyperlipidemia is one of the causes of angina. The measurement units of four indicators（TC、TG、HDL-C、LDL-C）are "mmol/L" | Change from base line on the tenth day |
| Change of fasting blood glucose | It is one of the causes of angina(especially for patients with diabetes).The measurement unit is "mmol/L" | Change from base line on the tenth day |
| The blood concentration of magnesium lithospermate B | Population pharmacokinetics test is in order to study the relationship between the population pharmacokinetics and clinical outcome. Magnesium lithospermate B is the main effective components of Salvianolate injection.The detection of the blood concentration of magnesium lithospermate B from both salvianolate injection group and salvianolate injection and aspirin group is necessary. | At the discretional two time points from the time point after treatment(0h,0.25h(15min),0.5h,0.75h(45min),1h,1.17h(70min),1.33h(80min),1.67h(100min),2h,2.5h,3h,4h,5h,7h,9h,13h,25h) |
| The blood concentration of salicylic acid | Population pharmacokinetics test is in order to study the relationship between the population pharmacokinetics and clinical outcome. Salicylic acid is a kind of metabolite of aspirin. The detection of the blood concentration of salicylic acid from both aspirin group and salvianolate injection and aspirin group is necessary. | At the discretional two time points from the time point after treatment(0h,0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,9h,10h,12h) |
| Change of basic life sign | In the medical care system, body temperature, blood pressure and pulse are the most important and basic three physiological parameters of the vital signs | Change from base line on the tenth day |
| Gastrointestinal symptoms | Change from base line on the tenth day |
| Change of stool routine | The stool routine includes stool properties, lipid droplets, and white blood cell count | Change from base line on the tenth day |
| Change of routine blood test | The routine blood test includes white blood cell count, neutral cell ratio, lymphocyte ratio, single nuclear cell ratio, red blood cell count, hemoglobin, platelet count | Change from base line on the tenth day |
| Change of urine routine | The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar | Change from base line on the tenth day |
| Change of liver function | The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase | Change from base line on the tenth day |
| Change of renal function | The renal function includes creatinine,usea nitrogen | Change from base line on the tenth day |
| Change of fecal occult blood | In order to monitor the safety of the digestive tract (if there is bleeding) | Change from base line on the tenth day |
| Change of APTT | An index to reflect the status of endogenous coagulation system | Change from base line on the tenth day |
| Change of TT | An index to reflect the time consuming from the fibrinogen into fibrin | Change from base line on the tenth day |
| Change of FIB | An index to reflect the content of fibrinogen | Change from base line on the tenth day |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |