NCT04022031

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 13, 2019

Last Update Submit

July 16, 2019

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 medicineDRUG

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

Exposed group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)