Status:
COMPLETED
Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI
Lead Sponsor:
Shenyang Northern Hospital
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 Yan...
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 targ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
681 Patients enrolled
Trial Details
Trial ID
NCT03809273
Start Date
August 1 2019
End Date
December 31 2020
Last Update
September 10 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
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 Municipality, China
3
Peking University People's Hospital
Beijing, Beijing Municipality, China
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China