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

Shenyang Northern Hospital

Status and phase

Unknown

Phase 4

Conditions

Percutaneous Coronary Intervention

Treatments

Drug: Trimetazidine

Drug: Yangxinshi

Drug: Yangxinshi mimic

Drug: Trimetazidine mimic

Study type

Interventional

Funder types

Other

Identifiers

NCT03809273

GrowfulPower-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

668 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.