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
Overview
- Phase
- Phase 4
- Intervention
- Wen Xin granule
- Conditions
- Coronary Heart Disease
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 502
- Primary Endpoint
- Major adverse cardiovascular events
- Last Updated
- 5 years ago
Overview
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.
Investigators
Jun Li
Director of cardiovascular department of Guang'anmen Hospital.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
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.
Intervention: Atorvastatin Calcium
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.
Intervention: Isosorbide Mononitrate Tab 20 MG
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.
Intervention: Metoprolol Tartrate Tab 25 MG
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.
Intervention: Aspirin Enteric-coated Tablets
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.
Intervention: Trimetazidine Dihydrochloride Tablets
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.
Intervention: glyceryl trinitrate
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.
Intervention: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
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.
Intervention: Atorvastatin Calcium
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.
Intervention: Isosorbide Mononitrate Tab 20 MG
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.
Intervention: Metoprolol Tartrate Tab 25 MG
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.
Intervention: Aspirin Enteric-coated Tablets
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.
Intervention: 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.
Intervention: Trimetazidine Dihydrochloride Tablets
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.
Intervention: glyceryl trinitrate
Outcomes
Primary Outcomes
Major adverse cardiovascular events
Time Frame: 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 Outcomes
- TCM symptom scale score(Before treatment, four and eight weeks after treatment.)
- Seattle angina questionnaire(Before treatment, four and eight weeks after treatment.)
- The thrombelastograph(Before treatment and at eight weeks after treatment.)