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

• Sponsor: Shenyang Northern Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03809273
• Collaborator: (none)
• Enrollment: 668
• Locations: 15
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site: 44.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention	Drug: Yangxinshi; Drug: Trimetazidine; Drug: Yangxinshi mimic; Drug: Trimetazidine mimic	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 668 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Yangxinshi	Drug: Yangxinshi; Yangxinshi pill 3 pills /tid; Drug: Trimetazidine mimic; Trimetazidine mimic tablets 20mg/tid
Active Comparator: Trimetazidine	Drug: Trimetazidine; Trimetazidine 20mg/tid; Drug: Yangxinshi mimic; Yangxinshi mimic tablets 3 pills /tid

Outcome Measures

Primary Outcome Measures

1. Change in METs assessed by the CPET [24 weeks]

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

Secondary Outcome Measures

1. Changes of anaerobic threshold (AT) by CPET [24 weeks]

2. Incidence of major cardiovascular events (MACE) [4,12,24 and 28 weeks]

3. PHQ-9 Depression Scale [24 weeks]

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

4. Changes of Seattle Angina Questionnaire [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 [24 weeks]

6. The proportion of METs>7 patients [24 weeks]

   MET=Metabolic Equivalent of Task

7. Changes of VO2max by CPET [24 weeks]

8. Changes of VO2/HR by CPET [24 weeks]

9. Changes of VO2/W by CPET [24 weeks]

10. GAD-7 Anxiety Screening Scale [24 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui	China
2	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing	China
3	Peking University People's Hospital	Beijing	Beijing	China
4	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China
5	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China
6	Cangzhou Central Hospital	Cangzhou	Hebei	China
7	Hebei General Hospital	Shijiazhuang	Hebei	China
8	Changchun Traditional Medicine University Affiliated Hospital	Changchun	Jilin	China
9	The Second Hospital of Dalian Medical University	Dalian	Liaoning	China
10	General Hospital of Northern Theater Command	Shenyang	Liaoning	China	110016
11	Jinan Central Hospital Affiliated to Shandong University	Jinan	Shandong	China
12	Shandong Provincial Hospital	Jinan	Shandong	China
13	Qingdao Municipal Hospital	Qingdao	Shandong	China
14	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China
15	First Hospital of Shanxi Medical University	Taiyuan	Shanxi	China

Sponsors and Collaborators

• Shenyang Northern Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Han Yaling, Director, clinical professor, Shenyang Northern Hospital
• ClinicalTrials.gov Identifier: NCT03809273
• Other Study ID Numbers: GrowfulPower-001
• First Posted: Jan 18, 2019
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Han Yaling, Director, clinical professor, Shenyang Northern Hospital: Cardiopulmonary Exercise Test
• Additional relevant MeSH terms: Trimetazidine

Study Results

No Results Posted as of Oct 19, 2020