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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
164
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.
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.
Incidence Rate of Major Adverse Cardiovascular Events (MACE)
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.
Time frame: Within 48 weeks after randomization
Traditional Chinese Medicine Syndrome Score
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.
Time frame: Baseline (day 0), week 6, week 12, week 24, week 36, week 48
Echocardiographic Parameters of Cardiac Structure and Function
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.
Time frame: Baseline, week 12
24-Hour Holter Monitoring Parameters
Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc.
Time frame: Baseline, week 12
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
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.
Time frame: Baseline, week 6, week 12, week 24, week 36, week 48
Creatine Kinase-Myocardial Band (CK-MB)
Serum CK-MB measured from fasting blood samples.
Time frame: Baseline, week 12
Serum Lipid Profile
Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
Time frame: Baseline, week 12
Fasting Glucose
Fasting blood glucose measured using standard laboratory methods.
Time frame: 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.
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.
Time frame: Baseline, week 12
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