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

Phase 4

Recruiting

• Conditions: Chronic Coronary Syndrome
• Interventions: Drug: Yangxinshi tablet; Other: Basic medication

• Registration Number: NCT06171061
• Lead Sponsor: Shandong First Medical University

Brief Summary

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).

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 Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-14
• Study Start: 2023-12-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Yangxinshi tablet	basic medication + Yangxinshi tablet
Control group	Basic medication	basic medication.

Primary Outcome Measures

Name	Time	Method
6MWD	24 weeks after treatment	The 6-min walking distance

Secondary Outcome Measures

Name	Time	Method
Borg scale	24 weeks after treatment	score range: 0\~10,higher scores mean a worse outcome.
MACCE	after 4, 8, 12, 16, 20, and 24 weeks of treatment	incidence of major adverse cardiovascular and cerebrovascular events (MACCE)

Trial Locations

Locations (32)

Shapingba District People's Hospital of Chongqing; 🇨🇳 Chongqing, Chongqing, China

Zhengzhou Seventh People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Binzhou Medical University Hospital; 🇨🇳 Binzhou, Shandong, China

Binzhou People's Hospital; 🇨🇳 Binzhou, Shandong, China

Dezhou Municiple Hospital; 🇨🇳 Dezhou, Shandong, China

Pingyuan County first People's Hospital; 🇨🇳 Dezhou, Shandong, China

Feicheng People's Hospital; 🇨🇳 Feicheng, Shandong, China

Shandong Health Group Feicheng Hospital; 🇨🇳 Feicheng, Shandong, China

Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China

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