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NCT Number: NCT03809273

Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI

This study compared the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the other half will receive Trimetazidine and Yangxinshi mimic tablets.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

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About this study

The Primary Purpose of this study is to compare the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine, The target patients are the people who underwent PCI for the first time and can be carried on Cardiopulmonary exercise test. The treatment period was 24 weeks. The patients were randomly divided into two groups.: A: Yangxinshi pill 3 pills /tid and Trimetazidine mimic tablets 20mg/tid B: Trimetazidine mimic tablets 20mg/tid and Yangxinshi pill 3 pills /tid The patients were followed up for 0 weeks, 4 weeks, 12 weeks, 24 weeks and 28 weeks after entering the group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18~ 75, gender is not limited;
  • The patient within two month after PCI operation for the first time;
  • The patient had 1-2 coronary artery lesions with complete revascularization:At least one drug eluting stent was implanted,and residual coronary artery stenosis after PCI <30%;
  • Have not revascularization plan within 6 months;
  • After being evaluated by clinicians on aerobic exercise ability,patients can carry out early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside the hospital;
  • Coronary heart disease patients with Qi Deficiency and Blood Stasis Syndrome;
  • Participants voluntarily participated in and signed informed consent;

Exclusion criteria

  • Patients was diagnosed with AMI as the first diagnosis in the past month, and then hospitalized for PCI operation;
  • Patients with absolute and relative contraindications in cardiopulmonary exercise test;
  • Any drug allergy to Yangxinshi pill and trimetazidine;
  • Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent medicine regularly in the past month;
  • Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs (such as massive hemorrhage, severe hypotension, etc.);
  • History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
  • Active bleeding disease within 6 months;
  • Combined with severe liver and kidney dysfunction (creatinine clearance ≤ 30ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 3 × upper limit of clinical reference), other lifethreatening serious primary or psychiatric diseases and malignant tumors
  • Hemoglobin <90 g/L;
  • Cardiac function (NYHA) grade IV or echocardiography LVEF < 30%;
  • Venous blood pressure <100/60 mmHg;
  • In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
  • The expected survival period is less than one year.;
  • Patients who are participating in other clinical studies.

Treatment and study plan

Yangxinshi

Drug

Yangxinshi pill 3 pills /tid

Trimetazidine

Drug

Trimetazidine 20mg/tid

Yangxinshi mimic

Drug

Yangxinshi mimic tablets 3 pills /tid

Trimetazidine mimic

Drug

Trimetazidine mimic tablets 20mg/tid

Primary outcomes

  1. Change in METs assessed by the CPET

    Time frame: 24 weeks

    MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test

Secondary outcomes

  1. Changes of anaerobic threshold (AT) by CPET

    Time frame: 24 weeks

  2. Incidence of major cardiovascular events (MACE)

    Time frame: 4,12,24 and 28 weeks

  3. PHQ-9 Depression Scale

    Time frame: 24 weeks

    PHQ=Patient health questionaire, score range: 0-27

  4. Changes of Seattle Angina Questionnaire

    Time frame: 24 weeks

    The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)

  5. Frequency of angina pectoris

    Time frame: 24 weeks

  6. The proportion of METs>7 patients

    Time frame: 24 weeks

    MET=Metabolic Equivalent of Task

  7. Changes of VO2max by CPET

    Time frame: 24 weeks

  8. Changes of VO2/HR by CPET

    Time frame: 24 weeks

  9. Changes of VO2/W by CPET

    Time frame: 24 weeks

  10. GAD-7 Anxiety Screening Scale

    Time frame: 24 weeks

    GAD=Generalized Anxiety Disorder, score range: 0~21

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective,Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial

Acronym: HEARTRIP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2019
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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