Clinical Study on Adjuvant Treatment of Coronary Heart Di... | NCT04022031

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

NCT04022031

Sponsor

Tianjin University of Traditional Chinese Medicine

Status

Unknown status

Last Update Posted

Jul 17, 2019Actual

Enrollment

12,400Estimated

Phase

Not provided

Conditions

Atherosclerotic Heart Disease With Angina Nos

Interventions

Chinese patent medicine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Estimated

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Jul 13, 2019

First Submission Date that Met QC Criteria

Jul 13, 2019

First Posted Date

Jul 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2019

Last Update Posted Date

Jul 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12,400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed group		Chinese patent medicine combined with western medicine routine	Drug: Chinese patent medicine
Non-exposed group		Western medicine routine treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chinese patent medicine	Drug	Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.	Exposed group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of cardiovascular events	These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).	one year

Secondary Outcomes

Measure	Description	Time Frame
Death from all causes		one year
Re-admission due to cardiovascular events		one year
Seattle Angina Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample