Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine

NCT04022031 | Unknown

• 1 other identifier: CSCD-TCM
• Study Type: observational
• Target: 12,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Heart Disease With Angina Nos

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiovascular events

  These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).

  one year

Secondary Outcomes (5)

• Death from all causes

  one year

• Re-admission due to cardiovascular events

  one year

• Seattle Angina Questionnaire

  three months

• Clinical biochemical test

  three months

• Film degree exam

  three months

Study Arms (2)

Exposed group

Chinese patent medicine combined with western medicine routine

Drug: Chinese patent medicine

Non-exposed group

Western medicine routine treatment

Interventions

Chinese patent medicine DRUG

Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.

Exposed group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Nankai Hospital, Tianjin Medical University General Hospital，a total of 5 hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead

Study Sites (1)

Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, feces, tongue coating

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)