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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

1200

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Shandong First Medical University

Investigators

  • 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)

December 18, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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