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| Name | Class |
|---|---|
| Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine | UNKNOWN |
| National Natural Science Foundation of China | OTHER_GOV |
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This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.
Coronary heart disease has remained the leading cause of death worldwide over the past decades. Unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardial infarction with high morbidity and mortality. Standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. However, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. Wen Xin granule, as a Chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. However, there is still insufficient evidence on his specific efficacy and safety. Therefor, we'd like to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wen Xin granule | Experimental | Patients are given Wen Xin granule by mouth, one dose daily for 2 months & Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid. |
|
| WXG placebo | Placebo Comparator | Patients are given Wen Xin granule placebo by mouth, one dose daily for 2 months & Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wen Xin granule | Drug | one dose daily, two times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death. | Record the incidence of major adverse cardiovascular events in one year by follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| The thrombelastograph | Parameters assessed by were R (represent clotting time), K and Angle (reflect clot strength and development), MA (maximum platelet-fibrin clot strength), CI (represents overall coagulability), and LY30 (represents lysis). | Before treatment and at eight weeks after treatment. |
| TCM symptom scale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, M.D. | Contact | +86 13051458913 | gamyylj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Li, M.D. | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28807510 | Background | Niccoli G, Montone RA, Lanza GA, Crea F. Angina after percutaneous coronary intervention: The need for precision medicine. Int J Cardiol. 2017 Dec 1;248:14-19. doi: 10.1016/j.ijcard.2017.07.105. Epub 2017 Aug 12. | |
| 10632302 | Background | Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000 Jan 10;160(1):25-37. doi: 10.1001/archinte.160.1.25. |
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Parallel Assignment
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It's a double-blind trial and includes two levels of blinding.
| Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet | Drug | one tablet daily. (for patients who can't use aspirin) |
|
| Atorvastatin Calcium | Drug | 20 mg tablet, one tablet each night. |
|
| Isosorbide Mononitrate Tab 20 MG | Drug | one tablet， twice daily. |
|
| Metoprolol Tartrate Tab 25 MG | Drug | 12.5 mg or 25 mg, two times daily. |
|
| Aspirin Enteric-coated Tablets | Drug | 100mg tablet, one tablet daily. |
|
| WXG placebo | Drug | one dose daily, two times per day. |
|
| Trimetazidine Dihydrochloride Tablets | Drug | 20 mg tablet, one tablet three times daily. |
|
| glyceryl trinitrate | Drug | be taken when angina pectoris attacks. |
|
TCM syndrome scale includes items of chest tightness, chest pain, heavy body, obesity, phlegm, dark complexion, tongue condition and pulse condition. The chest tightness and chest pain, have 4-grade options of none, mild, moderate and severe, marked as 0, 2, 4 and 6 respectively. The other items have two options of yes or no, marked as 0 and 1 respectively. The higher scores mean more serious symptoms. |
| Before treatment, four and eight weeks after treatment. |
| Seattle angina questionnaire | The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. Higher scores mean a better outcome. | Before treatment, four and eight weeks after treatment. |
| 25748771 | Background | Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr;28(2):283-93. doi: 10.3122/jabfm.2015.02.140189. |
| 22719784 | Result | Jiang M, Zhang C, Zheng G, Guo H, Li L, Yang J, Lu C, Jia W, Lu A. Traditional chinese medicine zheng in the era of evidence-based medicine: a literature analysis. Evid Based Complement Alternat Med. 2012;2012:409568. doi: 10.1155/2012/409568. Epub 2012 Jun 6. |
| 26972437 | Result | Zhang HJ, Wang ZX. Yin-yang and Zheng: Exported from Chinese medicine. Chin J Integr Med. 2014 Apr;20(4):250-5. doi: 10.1007/s11655-014-1777-z. Epub 2014 Apr 3. |
| 34774099 | Derived | Tian PP, Wu QJ, Li J, Chen HW, Wu J, Deng YW, Xie ZC, Zhao W, Tan YQ. Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. Trials. 2021 Nov 13;22(1):798. doi: 10.1186/s13063-021-05771-y. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D013607 | Tablets |
| D000069059 | Atorvastatin |
| C030397 | isosorbide-5-mononitrate |
| D008790 | Metoprolol |
| D014292 | Trimetazidine |
| D005996 | Nitroglycerin |
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010879 | Piperazines |
| D009574 | Nitro Compounds |
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