Coronary Heart Disease, Unstable Angina, Chinese Herbal Medicine
Conditions
Keywords
coronary heart disease, unstable angina, Chinese herbal medicine, Wen Xin granule, traditional Chinese medicine
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.
Interventions
DRUGWen Xin granule
one dose daily, two times per day.
one tablet daily. (for patients who can't use aspirin)
DRUGAtorvastatin Calcium
20 mg tablet, one tablet each night.
one tablet， twice daily.
12.5 mg or 25 mg, two times daily.
100mg tablet, one tablet daily.
DRUGWXG placebo
one dose daily, two times per day.
20 mg tablet, one tablet three times daily.
be taken when angina pectoris attacks.
Sponsors
Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine
National Natural Science Foundation of China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
It's a double-blind trial and includes two levels of blinding.
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
Contacts
Primary ContactJun Li, M.D.
Outcome results
None listed