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Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization

27 mai 2026 mis à jour par: Liu Qiang
  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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

164

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 exclusion criteria (bleeding history within 1 month, active bleeding, bleeding tendency, currently using anticoagulants)
  11. Participants in other interventional clinical trials within the past month
  12. Allergy to known components of the investigational drug (Qidan Xiaohe Granules)
  13. Other conditions deemed unsuitable for participation in the trial by the investigator

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Qidan 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.
Comparateur placebo: 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.
Médicament: Placebo + 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence Rate of Major Adverse Cardiovascular Events (MACE)
Délai: 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.
Within 48 weeks after randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Traditional Chinese Medicine Syndrome Score
Délai: 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.
Baseline (day 0), week 6, week 12, week 24, week 36, week 48
Echocardiographic Parameters of Cardiac Structure and Function
Délai: 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.
Baseline, week 12
24-Hour Holter Monitoring Parameters
Délai: Baseline, week 12
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)
Délai: 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.
Baseline, week 6, week 12, week 24, week 36, week 48
Creatine Kinase-Myocardial Band (CK-MB)
Délai: Baseline, week 12
Serum CK-MB measured from fasting blood samples.
Baseline, week 12
Serum Lipid Profile
Délai: Baseline, week 12
Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
Baseline, week 12
Fasting Glucose
Délai: Baseline, week 12
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.
Délai: 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.
Baseline, week 12

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Red blood cell count
Délai: Baseline, week 12
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
Délai: 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.
Baseline, week 12
White blood cell count
Délai: 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.
Baseline, week 12
Platelet count
Délai: 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.
Baseline, week 12
Haematocrit
Délai: 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.
Baseline, week 12
Alanine transaminase
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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
Délai: Baseline, week 12
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Liu Qiang

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

14 mai 2026

Première soumission répondant aux critères de contrôle qualité

27 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ZSLL-KY-2026-028-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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