Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Chinese Herbal Medicine; Unstable Angina; Coronary Heart Disease

Treatments: Drug: Trimetazidine Dihydrochloride Tablets; Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet; Drug: glyceryl trinitrate; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: Aspirin Enteric-coated Tablets; Drug: Atorvastatin Calcium; Drug: WXG placebo; Drug: Wen Xin granule

Study type: Interventional

Funder types: Other

Identifiers

NCT04661709

Wenxin granule-20201122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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502 participants in 2 patient groups, including a placebo group

Wen Xin granule

Experimental group

Description:

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.

Treatment:

Drug: Wen Xin granule

Drug: Isosorbide Mononitrate Tab 20 MG

Drug: Atorvastatin Calcium

Drug: Aspirin Enteric-coated Tablets

Drug: glyceryl trinitrate

Drug: Metoprolol Tartrate Tab 25 MG

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet

Drug: Trimetazidine Dihydrochloride Tablets

WXG placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: WXG placebo

Drug: Isosorbide Mononitrate Tab 20 MG

Drug: Atorvastatin Calcium

Drug: Aspirin Enteric-coated Tablets

Drug: glyceryl trinitrate

Drug: Metoprolol Tartrate Tab 25 MG

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet

Drug: Trimetazidine Dihydrochloride Tablets