Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）

NCT05978089 | Unknown Phase 4

• 1 other identifier: Growful2201YXS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in patients with chronic coronary syndrome (CCS).

Conditions

Chronic Coronary Syndrome

Keywords

Cardiopulmonary Exercise Test; Yangxinshi

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)

  MET=Metabolic Equivalent of Task

  24 weeks

Secondary Outcomes (11)

• anaerobic threshold

  24 weeks

• oxygen pulse

  24 weeks

• maximal exercise ventilation

  24 weeks

• electrocardiogram (ECG)

  24 weeks

• CCS angina classification

  24 weeks

Other Outcomes (4)

• Liver function

  24 weeks

• Renal function

  24 weeks

• Myocardial markers

  24 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Yangxinshi tablets

Drug: Yangxinshi tablet

Control group

PLACEBO COMPARATOR

Yangxinshi tablet simulants

Drug: Yangxinshi tablet simulants

Interventions

Yangxinshi tablet DRUG

The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.

Also known as: Yangxinshi

Treatment group

Yangxinshi tablet simulants DRUG

The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the following criteria must be met to participate in the study:
• Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed tomography angiography (CTA) (including patients with more than 1 year of revascularization)
• Meet the TCM standard of Qi deficiency and blood stasis syndrome
• MET \< 5 measured by cardiopulmonary exercise test (treadmill)
• Age between 18 and 75 years (including both age limits), with no limitation on sex
• Understanding and voluntarily signing the written informed consent

You may not qualify if:

• All the following criteria must not be met to participate in the study:
• Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests
• Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)
• Individuals with serious primary diseases related to the liver, kidney, and hematopoietic system, acute infectious diseases, and mental illness and individuals with other diseases who are not suitable for cardiopulmonary exercise tests
• Individuals with a revascularization plan within a month
• Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG
• Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details)
• Individuals with New York Heart Association (NYHA) cardiac function class III and IV
• Individuals with acute cerebrovascular disease
• Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg
• Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9
• Individuals with allergies or abnormal drug reactions to the test drugs
• Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant within six months, have a positive pregnancy test, and cannot take effective contraceptive measures during the study period
• Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary Chinese medicines with similar curative effects within the past 7 days (please refer to Appendix 12 for the names of proprietary Chinese medicines)
• Individuals who have participated in other clinical trials within the past 3 months

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (6)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

The First Affiliated Hospital of Henan University of CM

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

Yangxinshi

Study Officials

• Wang Xian

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Xian

CONTACT

010-84013276; wx650515@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 7, 2023
• Study Start: November 8, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

CN (6)