NCT04022031UnknownNot Applicable
Prospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Tianjin University of Traditional Chinese Medicine1 site in 1 country12,400 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 12,400
- Locations
- 1
- Primary Endpoint
- Incidence of cardiovascular events
Study Overview
Brief Summary
A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntarily participate, understand and sign the informed consent form;
- •Age 35-75 years old, gender is not limited;
- •Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
- •Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.
Exclusion Criteria
- •Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
- •Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
- •Pregnant women, lactating women or women of childbearing age who have birth requirements;
- •Mental patients, or cognitive dysfunction;
- •Participated in other clinical trials in the last 3 months;
- •Allergic persons, or those known to be allergic to therapeutic drugs;
- •It is expected that the compliance is poor and it is not possible to visit regularly;
- •Patients who do not have a current address or whose current address is incomplete and have no contact number;
- •The investigator believes that there are other situations that are not suitable for the trial.
Arms & Interventions
Exposed group
Chinese patent medicine combined with western medicine routine
Intervention: Chinese patent medicine (Drug)
Outcomes
Primary Outcomes
Incidence of cardiovascular events
Time Frame: one year
These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).
Secondary Outcomes
- Re-admission due to cardiovascular events(one year)
- Film degree exam(three months)
- Death from all causes(one year)
- Seattle Angina Questionnaire(three months)
- Clinical biochemical test(three months)
Investigators
Chunquan Yu
researcher
Tianjin University of Traditional Chinese Medicine
Study Sites (1)
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