Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization
27 de mayo de 2026 actualizado por: Liu Qiang
- Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery;
- Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery;
- 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
164
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Liu Qiang, PhD
- Número de teléfono: +86 13588121905
- Correo electrónico: 19981011@zcmu.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age: 18-80 years old;
- no gender limitation;
- Meets the diagnostic criteria for coronary heart disease;
- Accepts effective PCI procedure;
- Voluntarily participates and signs a written informed consent form.
Exclusion Criteria:
- Severe hepatic and/or renal insufficiency
- Severe electrolyte disorders
- Severe hematological diseases or malignant tumors
- Pregnant or breastfeeding women
- Patients with mental illness
- Cognitive impairment (e.g., dementia, post-stroke cognitive impairment) leading to inability to communicate normally
- Planning to undergo another revascularization surgery in the near future
- 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.)
- Acute pulmonary embolism and chronic lung diseases with dyspnea symptoms (occurring at rest or with minimal exertion)
- Explicit exclusion criteria (bleeding history within 1 month, active bleeding, bleeding tendency, currently using anticoagulants)
- Participants in other interventional clinical trials within the past month
- Allergy to known components of the investigational drug (Qidan Xiaohe Granules)
- Other conditions deemed unsuitable for participation in the trial by the investigator
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Experimental Group
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 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.
|
|
Comparador de placebos: Control Group
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence Rate of Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: 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.
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Within 48 weeks after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Traditional Chinese Medicine Syndrome Score
Periodo de tiempo: 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.
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Baseline (day 0), week 6, week 12, week 24, week 36, week 48
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Echocardiographic Parameters of Cardiac Structure and Function
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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24-Hour Holter Monitoring Parameters
Periodo de tiempo: Baseline, week 12
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Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc.
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Baseline, week 12
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Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Periodo de tiempo: Baseline, week 6, week 12, week 24, week 36, week 48
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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.
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Baseline, week 6, week 12, week 24, week 36, week 48
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Creatine Kinase-Myocardial Band (CK-MB)
Periodo de tiempo: Baseline, week 12
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Serum CK-MB measured from fasting blood samples.
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Baseline, week 12
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Serum Lipid Profile
Periodo de tiempo: Baseline, week 12
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Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
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Baseline, week 12
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Fasting Glucose
Periodo de tiempo: Baseline, week 12
|
Fasting blood glucose measured using standard laboratory methods.
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Baseline, week 12
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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.
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Red blood cell count
Periodo de tiempo: Baseline, week 12
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As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.
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Baseline, week 12
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Haemoglobin concentration
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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White blood cell count
Periodo de tiempo: Baseline, week 12
|
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.
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Baseline, week 12
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Platelet count
Periodo de tiempo: Baseline, week 12
|
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.
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Baseline, week 12
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Haematocrit
Periodo de tiempo: Baseline, week 12
|
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.
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Baseline, week 12
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Alanine transaminase
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Aspartate transaminase
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Alkaline phosphatase
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Potassium
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Sodium
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Total bilirubin
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Blood urea nitrogen
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Creatinine
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Uric acid
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Homocysteine
Periodo de tiempo: Baseline, week 12
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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.
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Baseline, week 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZSLL-KY-2026-028-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .