Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLiu Qiang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-80 years old;
no gender limitation;
Meets the diagnostic criteria for coronary heart disease;
Accepts effective PCI procedure;
Disqualifiers
Severe hepatic and/or renal insufficiency
Severe electrolyte disorders
Severe hematological diseases or malignant tumors
Pregnant or breastfeeding women
Trial design
Design model
Parallel
Treatments tested in this trial
Qidan Xiaoke Granules + Standard Medical Therapy
DrugParticipants 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.
Placebo + Standard Medical Therapy
DrugParticipants 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.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 randomizationSecondary outcomes
1
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 482
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 123
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 124
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 48Other outcomes
1
Red blood cell count
As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.
Time frame
Baseline, week 122
Haemoglobin concentration
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
Time frame
Baseline, week 123
White blood cell count
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
Time frame
Baseline, week 124
Platelet count
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
Time frame
Baseline, week 12Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liu Qiang
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor institution
Source ClinicalTrials.gov
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