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

Sponsor
Liu Qiang
Study ID
NCT07616544
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Myocardial Revascularization
  • Percutaneous Coronary Intervention

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Incidence Rate of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Within 48 weeks after randomization ]

Central Contacts

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