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NCT Number: NCT07616544

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

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.

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Key information

Conditions

Percutaneous Coronary Intervention Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Myocardial Revascularization Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence Rate of Major Adverse Cardiovascular Events (MACE)

    Time frame: 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.

Secondary outcomes

  1. Traditional Chinese Medicine Syndrome Score

    Time frame: 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.

  2. Echocardiographic Parameters of Cardiac Structure and Function

    Time frame: 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.

  3. 24-Hour Holter Monitoring Parameters

    Time frame: Baseline, week 12

    Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc.

  4. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: 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.

  5. Creatine Kinase-Myocardial Band (CK-MB)

    Time frame: Baseline, week 12

    Serum CK-MB measured from fasting blood samples.

  6. Serum Lipid Profile

    Time frame: Baseline, week 12

    Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.

  7. Fasting Glucose

    Time frame: Baseline, week 12

    Fasting blood glucose measured using standard laboratory methods.

  8. 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

    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.

Other outcomes

  1. Red blood cell count

    Time frame: 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.

  2. Haemoglobin concentration

    Time frame: 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.

  3. White blood cell count

    Time frame: 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.

  4. Platelet count

    Time frame: 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.

  5. Haematocrit

    Time frame: 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.

  6. Alanine transaminase

    Time frame: 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.

  7. Aspartate transaminase

    Time frame: 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.

  8. Alkaline phosphatase

    Time frame: 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.

  9. Potassium

    Time frame: 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.

  10. Sodium

    Time frame: 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.

  11. Total bilirubin

    Time frame: 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.

  12. Blood urea nitrogen

    Time frame: 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.

  13. Creatinine

    Time frame: 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.

  14. Uric acid

    Time frame: 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.

  15. Homocysteine

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Qiang, PhD

CONTACT

[email protected]

+86 13588121905

Sponsors and collaborators

Lead sponsor

Liu Qiang

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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