Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

April 16, 2024 updated by: Shandong First Medical University

Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial

This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • Shapingba District People's Hospital of Chongqing
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Zhengzhou Seventh People's Hospital
    • Shandong
      • Binzhou, Shandong, China
        • Not yet recruiting
        • Binzhou Medical University Hospital
      • Binzhou, Shandong, China
        • Not yet recruiting
        • Binzhou People's Hospital
      • Dezhou, Shandong, China
        • Not yet recruiting
        • Dezhou Municiple Hospital
      • Dezhou, Shandong, China
        • Not yet recruiting
        • Pingyuan County first People's Hospital
      • Feicheng, Shandong, China
        • Recruiting
        • Feicheng People's Hospital
      • Feicheng, Shandong, China
        • Recruiting
        • Shandong health group feicheng hospital
      • Jinan, Shandong, China
        • Not yet recruiting
        • Jinan Central Hospital
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
          • Yuan Haitao, Professor
      • Jinan, Shandong, China
        • Recruiting
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
        • Contact:
          • Lu Feng, Professor
      • Jinan, Shandong, China
        • Not yet recruiting
        • Jinan Zhangqiu District People's Hospital
      • Jinan, Shandong, China
        • Not yet recruiting
        • The Fourth People's Hospital of Jinan
      • Liaocheng, Shandong, China
        • Not yet recruiting
        • Liaocheng People's Hospital
      • Liaocheng, Shandong, China
        • Not yet recruiting
        • Gaotang county people's hospital
      • Liaocheng, Shandong, China
        • Not yet recruiting
        • Liaocheng Hospital of Traditional Chinese Medicine
      • Liaocheng, Shandong, China
        • Not yet recruiting
        • the Second People's Hospital of Liaocheng
      • Linqing, Shandong, China
        • Not yet recruiting
        • Linqing City People's Hospital
      • Linyi, Shandong, China
        • Not yet recruiting
        • Linyi People's Hospital
      • Longkou, Shandong, China
        • Not yet recruiting
        • Longkou People Hosptial
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qingdao Municipal Hospital
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qingdao Central Hospital
      • Qingdao, Shandong, China
        • Recruiting
        • Affiliated Hospital of Qingdao University
      • Qingdao, Shandong, China
        • Recruiting
        • Hospital of Cardiovascular Diseases Affiliated to Qingdao University
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qingdao Fuwai Hospital
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Shandong University Qilu Hospital Qingdao District
      • Taian, Shandong, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Shandong First Medical University
      • Taian, Shandong, China
        • Not yet recruiting
        • Xintai People's Hospital
      • Tengzhou, Shandong, China
        • Not yet recruiting
        • Tengzhou Central People's Hospital
      • Weifang, Shandong, China
        • Not yet recruiting
        • Weifang City People's Hospital
      • Weifang, Shandong, China
        • Not yet recruiting
        • Weifang City Yidu Central Hospital
      • Yantai, Shandong, China
        • Not yet recruiting
        • Yantai Hospital of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 18-75 years;
  2. CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or >3 months after coronary revascularization;
  3. moderately to severely limited exercise tolerance: the maximum 6MWD is < 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is < 5 METs;
  4. voluntary participation and signing of informed consent.

Exclusion Criteria:

  1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);
  2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan;
  3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;
  4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
basic medication + Yangxinshi tablet
Drug: Yangxinshi tablet
In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.
Other Names:
  • Yangxinshi
Other: Control group
basic medication.
Other: Basic medication
The control group will be given basic medication only. The treatment period is 24 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6MWD
Time Frame: 24 weeks after treatment
The 6-min walking distance
24 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Borg scale
Time Frame: 24 weeks after treatment
score range: 0~10,higher scores mean a worse outcome.
24 weeks after treatment
MACCE
Time Frame: after 4, 8, 12, 16, 20, and 24 weeks of treatment
incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
after 4, 8, 12, 16, 20, and 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong First Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuan Haitao, Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GrowfulPower-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings