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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
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| Control Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qidan Xiaoke Granules + Standard Medical Therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 12 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Qiang, PhD | Contact | +86 13588121905 | 19981011@zcmu.edu.cn |
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Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2026 |
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| Placebo + Standard Medical Therapy | Drug | 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. |
|
| 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. | Baseline, week 12 |
| 24-Hour Holter Monitoring Parameters | Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc. | 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. | 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. | Baseline, week 12 |
| Serum Lipid Profile | Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods. | Baseline, week 12 |
| Fasting Glucose | Fasting blood glucose measured using standard laboratory methods. | 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. | Baseline, week 12 |
| Baseline, week 12 |
| 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. | Baseline, week 12 |
| 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. | Baseline, week 12 |
| Haematocrit | 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. | Baseline, week 12 |
| Alanine transaminase | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Aspartate transaminase | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Alkaline phosphatase | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Potassium | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Sodium | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Total bilirubin | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Blood urea nitrogen | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Creatinine | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Uric acid | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| Homocysteine | As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers. | Baseline, week 12 |
| May 14, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2026 | May 14, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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