A randomized controlled trial of Naoxintong Capsule to reduce major cardiovascular adverse events (MACE) in patients with acute coronary syndrome (ACS)
- Conditions
- Acute coronary syndrome
- Registration Number
- ITMCTR2000003509
- Lead Sponsor
- The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Aged 30-75 years;
(2) Meet the diagnostic criteria of ACS;
(3) Subjects voluntarily participate in this study and sign written informed consent.
(1) Patients with severe arrhythmia, such as type II ATRIoventricular block and pathological sinoatrial node syndrome; Severe hypotension, hypertension emergency, severe heart failure (grade III or above cardiac function, not effectively controlled), acute cardiac tamponade, acute pulmonary edema, etc.
(2) Patients with hemorrhagic cerebrovascular accident and gastrointestinal bleeding;
(3) Hemophilia, severe thrombocytopenia, abnormal coagulation function;
(4) Complications of severe diabetes, such as diabetic ketoacidosis;
(5) patients with severe liver and kidney function impairment (3 times of the normal upper limit of serum alanine aminotransferase > and/or serum creatinine level >= 265umol/L);
(6) Patients with malignant tumors and mental diseases;
(7) Patients who need coronary bypass graft (heart bypass);
(8) Allergic to the known ingredients of the test drugs or allergic constitution;
(9) Severe hypotension;
(10) Severe respiratory diseases such as chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism.
(11) women who are breast-feeding or pregnant, or women of childbearing age who plan to become pregnant within 6 months after screening examination, or who are positive in urine pregnancy test; Or male patients with fertility or sperm donation plans;
(12) Suspected or proven history of alcohol or drug abuse;
(13) Screening patients who had participated in other drug clinical trials within 3 months before the examination;
(14) Other patients who were not considered appropriate to participate in this study by the researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of major adverse cardiovascular events;
- Secondary Outcome Measures
Name Time Method Blood tests, Electrocardiogram (ECG);Seattle Angina Scale;Clinical efficacy evaluation;Curative effect of TCM syndromes;