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Effect of Qingre Huoxue Decoction on Clinical Outcome of Patients with Coronary Heart Disease after PCI: An Ambispective Cohort Study Based on Real-World Clinical Practice

Effect of Qingre Huoxue Decoction on Clinical Outcome of Patients with Coronary Heart Disease after PCI: An Ambispective Cohort Study Based on Real-World Clinical Practice

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044455
Enrollment
Unknown
Registered
2021-03-18
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Coronary Heart Disease after PCI

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years; 2. It meets the diagnostic criteria of coronary heart disease; 3. Stents were implanted into the target vessels for the first time; 4. It conforms to the definition of successful PCI operation; 5. The patients voluntarily participated in this study, signed a written informed consent form, and were willing to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Coronary heart disease should exclude myocardial ischemia, injury and necrosis caused by non-coronary atherosclerosis; 2. Those who died within 7 days after PCI; 3. With severe hepatorenal insufficiency, ALT and AST were defined as >5 ULN, and the creatinine clearance rate was less than 30mL/min; 4. Suffer from severe immunodeficiency diseases (such as HIV, etc.), malignant tumors, autoimmune diseases, severe cerebrovascular diseases, blood system diseases, etc., or other diseases that may significantly reduce life expectancy; 5. Pregnant or lactating women, mentally ill; 6. Those who did not take western medicine regularly after operation; 7. Those who participated in any drug clinical trial within 1 month before operation.

Design outcomes

Primary

MeasureTime frame
The incidence of major adverse cardiovascular events (MACCE) included cardiac death, recurrence of non-fatal myocardial infarction, stroke, revascularization of target vessels and hospitalization due to unstable angina pectoris;

Secondary

MeasureTime frame
complex endpoints(Incidence of cardiac death, non-fatal myocardial infarction and stroke);All-cause mortality;Incidence of cardiac death;Incidence of myocardial infarction;Incidence of ischemic stroke;Incidence of revascularization of target vessels;Incidence of in-stent thrombosis;Admission rate due to heart failure;Changes of cardiac function classification in Killip or NYHA;Changes in laboratory indicators, including blood analysis, biochemistry, blood lipids, blood coagulation, BNP, hsCRP, glycosylated hemoglobin, etc.;Evaluation of comprehensive curative effect, evaluation of angina pectoris symptoms, evaluation of electrocardiogram and changes of TCM syndrome score;The incidence of the total number of compound end-point events;Echocardiography includes changes of left ventricular ejection fraction, left atrial diameter, left ventricular end-diastolic diameter, wall motion and ventricular systolic and diastolic function.;

Countries

China

Contacts

Public ContactWei Wu

The First Clinical College of Guangzhou University of Traditional Chinese Medicine

zywuwei@163.com+86 13570211913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026