Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
- Conditions
- Coronary Heart DiseaseUnstable AnginaChinese Herbal Medicine
- Interventions
- Registration Number
- NCT04661709
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 502
- aged between 35 and 75 years of age;
- diagnosed with CAD through coronary arteriography, clinically diagnosed with UAP in low or medium risk;
- belong to Yang deficiency and blood stasis syndrome according to TCM, and give written informed consent.
- For the diagnostic criteria of UAP, the investigators will refer to 2014 AHA/ACC Guidelines for the Diagnosis and Management of Non-ST-Elevation Acute Coronary Syndromes.
- For the TCM diagnostic criteria, the investigators will refer to Guidelines for Clinical Research into New Traditional Chinese Medicine Drugs for Chest Obstruction (2002 edition).
- chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia
- with New York Heart Association class III or IV heart failure, in acute phase of cerebral infarction;
- with uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg in the resting state)
- with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia;
- female patients in pregnancy or lactation;
- by participating in other clinical trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WXG placebo Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet 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. Wen Xin granule Aspirin Enteric-coated Tablets 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 WXG placebo 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. Wen Xin granule Atorvastatin Calcium 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. Wen Xin granule Trimetazidine Dihydrochloride Tablets 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. Wen Xin granule Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet 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. Wen Xin granule Isosorbide Mononitrate Tab 20 MG 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. Wen Xin granule Metoprolol Tartrate Tab 25 MG 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 Isosorbide Mononitrate Tab 20 MG 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. WXG placebo Aspirin Enteric-coated Tablets 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. Wen Xin granule Wen Xin granule 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 Atorvastatin Calcium 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. WXG placebo Metoprolol Tartrate Tab 25 MG 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. WXG placebo Trimetazidine Dihydrochloride Tablets 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. Wen Xin granule glyceryl trinitrate 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 glyceryl trinitrate 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.
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular events Record the incidence of major adverse cardiovascular events in one year by follow-up. Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.
- Secondary Outcome Measures
Name Time Method Seattle angina questionnaire Before treatment, four and eight weeks after treatment. 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.
TCM symptom scale score Before treatment, four and eight weeks after treatment. 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.
The thrombelastograph Before treatment and at eight weeks after treatment. 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).