Coronary Artery Disease, Myocardial Revascularization, Percutaneous Coronary Intervention
Conditions
Brief summary
1. Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery; 2. Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery; 3. Demonstrate the advantages of traditional Chinese medicine rehabilitation treatment in the postoperative management of coronary revascularization surgery and provide high-level evidence-based medical evidence for the development of traditional Chinese medicine rehabilitation treatment plans.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients who have undergone coronary revascularization will be randomly assigned to receive either Qidan Xiaohe Granules or a matching placebo, in addition to standard medical therapy. The treatment period lasts 12 weeks, and participants will be followed up for a total of 48 weeks. The main goal is to see whether adding the Chinese herbal medicine reduces the occurrence of major adverse cardiovascular events such as death, heart attack, recurrent chest pain, or repeat revascularization. Secondary goals include improvements in heart function, quality of life, and traditional Chinese medicine symptom scores. Safety will be monitored throughout the study. The results will help determine whether this herbal formula can be recommended as an effective and safe rehabilitation treatment for patients after coronary revascularization.
Interventions
DRUGQidan Xiaoke Granules + Standard Medical Therapy
Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy, statins, beta-blockers, ACEI/ARB, and other medications as clinically indicated. In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks. The granules are dissolved in warm water before administration. The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline. The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.
DRUGPlacebo + Standard Medical Therapy
Participants in this arm receive the same standard medical therapy as the experimental group. In addition, they take a placebo matching the Qidan Xiaoke Granules in appearance, taste, odor, and packaging at the same dosage regimen: one sachet twice daily for 12 weeks. The placebo has no pharmacological activity related to the investigational product. The treatment and follow-up schedule are identical to the experimental group.
Sponsors
Liu Qiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-80 years old; 2. no gender limitation; 3. Meets the diagnostic criteria for coronary heart disease; 4. Accepts effective PCI procedure; 5. Voluntarily participates and signs a written informed consent form.
Exclusion criteria
1. Severe hepatic and/or renal insufficiency 2. Severe electrolyte disorders 3. Severe hematological diseases or malignant tumors 4. Pregnant or breastfeeding women 5. Patients with mental illness 6. Cognitive impairment (e.g., dementia, post-stroke cognitive impairment) leading to inability to communicate normally 7. Planning to undergo another revascularization surgery in the near future 8. Other severe cardiovascular diseases (e.g., uncontrolled hypertension, angina pectoris, rapid arrhythmias, high-degree or complete atrioventricular block without a pacemaker implanted, acute severe aortic stenosis, decompensated heart failure (NYHA Class IV), deep vein thrombosis, obstructive hypertrophic cardiomyopathy, acute pericarditis or myocarditis, acute endocarditis, acute aortic dissection, etc.) 9. Acute pulmonary embolism and chronic lung diseases with dyspnea symptoms (occurring at rest or with minimal exertion) 10. Explicit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Major Adverse Cardiovascular Events (MACE) | Within 48 weeks after randomization | MACE is defined as a composite endpoint including the following seven events: (1) all-cause death; (2) subacute stent thrombosis; (3) peri-procedural myocardial infarction; (4) recurrent myocardial infarction; (5) recurrent unstable angina; (6) repeat revascularization ; and (7) rehospitalization due to angina or heart failure. All events are adjudicated by an independent Clinical Endpoint Committee blinded to treatment allocation, based on source documents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese Medicine Syndrome Score | Baseline (day 0), week 6, week 12, week 24, week 36, week 48 | The scale evaluates 14 symptoms. Each symptom is scored as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). Tongue appearance (color, coating) and pulse pattern are also recorded. With higher scores indicating more severe TCM syndrome. Assessments are performed by two trained TCM physicians independently; discrepancies are resolved by a third senior physician. |
| Echocardiographic Parameters of Cardiac Structure and Function | Baseline, week 12 | Echocardiography is performed using a standardized protocol at each participating site. Parameters measured include: (1) Left ventricular ejection fraction ; (2) Left ventricular end-diastolic diameter (LVEDD); (3) Left ventricular end-systolic diameter (LVESD); (4) Left ventricular posterior wall thickness (LVPW); (5) Interventricular septal thickness (IVS); (6) E/A ratio (peak velocity of early to late diastolic filling); (7) Average E/e' ratio (mitral inflow to annular velocity). All measurements are performed by certified sonographers following a centralized training program. |
| 24-Hour Holter Monitoring Parameters | Baseline, week 12 | Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc. |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | Baseline, week 6, week 12, week 24, week 36, week 48 | The MLHFQ is a 21-item, self-administered questionnaire that assesses the impact of heart failure on health-related quality of life. Each item is scored from 0 (no impact) to 5 (very severe impact). With higher scores indicating worse quality of life. The questionnaire is administered in the validated Chinese version. |
| Creatine Kinase-Myocardial Band (CK-MB) | Baseline, week 12 | Serum CK-MB measured from fasting blood samples. |
| Serum Lipid Profile | Baseline, week 12 | Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods. |
| Fasting Glucose | Baseline, week 12 | Fasting blood glucose measured using standard laboratory methods. |
| Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded. | Baseline, week 12 | Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded. |
Contacts
CONTACTLiu Qiang, PhD
Outcome results
None listed