A multicenter, randomized, double-blind, multi-dose, parallel-controlled, phase II exploratory study on the treatment of chronic stable angina pectoris (sputum stasis and blockage) with Gua-Xie-Xin-Tong dropping pills
- Conditions
- Coronary Heart Disease
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) According to the diagnostic criteria of stable exertional angina pectoris, CCS grade I and II;
(2) Angina pectoris occurred more than 3 times a week on average one month before enrollment;
(3) The history of stable angina pectoris was more than 3 months;
(4) Angina pectoris symptoms, and at least one of the following evidence for the diagnosis of coronary heart disease:
A. history of myocardial infarction in the past;
B. had received coronary revascularization, including PCI and CABG;
C. coronary angiography or coronary CTA examination showed at least one coronary artery stenosis and lumen stenosis >= 50%, or myocardial ischemia of coronary heart disease was diagnosed by static or dynamic radionuclide myocardial scanning;
D. ischemic ECG changes: during angina pectoris attack, ST segment measured from 0.08 s after J point in the lead with R wave dominant in ECG showed horizontal or downward oblique depression, with depression >= 1.0 mm or ST segment elevation >= 1.0 mm compared with P-R segment.
(5) TCM syndrome differentiation belongs to the syndrome of phlegm and blood stasis obstructing collaterals, with more than 1 main symptom and more than 2 secondary symptoms;
(6) The age was 30-65 years old, with no gender limit;
(7) Informed consent, voluntary subjects. The process of obtaining informed consent is in accordance with GCP.
(1) The left main artery disease was not treated effectively;
(2) Clinical significance of valve disease, congenital heart disease, pulmonary embolism, chronic obstructive pulmonary disease, bronchial asthma, stroke, dissecting aneurysm, sick sinus syndrome, hypertrophic obstructive cardiomyopathy, acute myocarditis / pericarditis, congenital long QT syndrome;
(3) In patients with congestive heart failure NYHA grade III or IV or acute pulmonary edema, left ventricular ejection fraction (LVEF) was less than 50% on echocardiography;
(4) Patients with non sinus rhythm, or with arrhythmia (such as degree II, III atrioventricular block, bundle branch block, preexcitation syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, etc.), or with pacemaker or cardioverter;
(5) CABG or PCI within three months;
(6) Severe and uncontrolled hypertension (>=160 / 100mmhg), hypotension (<= 90 / 60mmhg);
(7) There are other factors that affect the changes of ECG ST-T, such as digitalis drug effect, electrolyte disorder, etc;
(8) Patients with severe primary diseases such as liver (alt, AST > 1.5 times of the upper limit of normal value), kidney (SCR > upper limit of normal value), hematopoietic system and other serious primary diseases, mental patients;
(9) Pregnant or lactating women or those who are ready for pregnancy recently.
(10) People with disabilities prescribed by law (blindness, deafness, dumb, mental retardation, etc.).
(11) Those who are allergic to the components of this preparation.
(12) Patients who are participating in clinical trials of other drugs within 4 weeks. Suspected or confirmed history of alcohol and drug abuse, or other situations that reduce the possibility of enrollment or complicate the enrollment according to the judgment of the researcher, such as frequent changes in the working environment, which may easily lead to loss of follow-up.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weekly nitroglycerin consumption;Seattle Angina scale score;Number of angina attacks per week;VAS score of pain degree;Duration of angina attack;Electrocardiogram treadmill exercise test;Symptoms of traditional Chinese Medicine;24-hour Holter myocardial ischemic load;Severity classification of angina pectoris;Resting and drug loading myocardial radionuclide imaging;
- Secondary Outcome Measures
Name Time Method