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

NCT07616544 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ZSLL-KY-2026-028-01
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery;
2. 2.Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery;
3. 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.

Conditions

Percutaneous Coronary Intervention; Myocardial Revascularization; Coronary Artery Disease

Outcome Measures

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.

  Within 48 weeks after randomization

Secondary Outcomes (8)

• Traditional Chinese Medicine Syndrome Score

  Baseline (day 0), week 6, week 12, week 24, week 36, week 48

• Echocardiographic Parameters of Cardiac Structure and Function

  Baseline, week 12

• 24-Hour Holter Monitoring Parameters

  Baseline, week 12

• Minnesota Living with Heart Failure Questionnaire (MLHFQ)

  Baseline, week 6, week 12, week 24, week 36, week 48

• Creatine Kinase-Myocardial Band (CK-MB)

  Baseline, week 12

Other Outcomes (15)

• Red blood cell count

  Baseline, week 12

• Haemoglobin concentration

  Baseline, week 12

• White blood cell count

  Baseline, week 12

Study Arms (2)

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.

Drug: Qidan Xiaoke Granules + Standard Medical Therapy

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.

Drug: Placebo + Standard Medical Therapy

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Liu Qiang: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Liu Qiang, PhD

CONTACT

+86 13588121905; 19981011@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share