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

Percutaneous Coronary Intervention Clinical Trial

— HEARTRIP  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03809273
• Other study ID #: GrowfulPower-001
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 668
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Drug:
• Yangxinshi
Yangxinshi pill 3 pills /tid
• Trimetazidine
Trimetazidine 20mg/tid
• Yangxinshi mimic
Yangxinshi mimic tablets 3 pills /tid
• Trimetazidine mimic
Trimetazidine mimic tablets 20mg/tid

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Changchun Traditional Medicine University Affiliated Hospital	Changchun	Jilin
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui
China	Jinan Central Hospital Affiliated to Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Hebei General Hospital	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in METs assessed by the CPET	MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test	24 weeks
Secondary	Changes of anaerobic threshold (AT) by CPET		24 weeks
Secondary	Incidence of major cardiovascular events (MACE)		4,12,24 and 28 weeks
Secondary	PHQ-9 Depression Scale	PHQ=Patient health questionaire, score range: 0-27	24 weeks
Secondary	Changes of Seattle Angina Questionnaire	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)	24 weeks
Secondary	Frequency of angina pectoris		24 weeks
Secondary	The proportion of METs>7 patients	MET=Metabolic Equivalent of Task	24 weeks
Secondary	Changes of VO2max by CPET		24 weeks
Secondary	Changes of VO2/HR by CPET		24 weeks
Secondary	Changes of VO2/W by CPET		24 weeks
Secondary	GAD-7 Anxiety Screening Scale	GAD=Generalized Anxiety Disorder, score range: 0~21	24 weeks