Pre-trial of Clinical Trial of Traditional Chinese Medicine Treatment for Elderly Patients With Coronary Heart Disease Who Are Still Symptomatic After Optimal Medical Treatment

NCT07041359 | Recruiting Phase 4

• 1 other identifier: 2024-ZX080
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effectiveness of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill in the elderly population with coronary heart disease and the safety of multiple medications

Conditions

Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (4)

• Seattle angina questionnaire

  The Seattle Angina Questionnaire (SAQ) consists of five distinct dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each dimension is scored independently, with a possible range of 0 to 100 points. A higher score on any SAQ dimension indicates a better patient condition or experience.

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

• The Canadian Cardiovascular Society grading of angina pectoris

  The Canadian Cardiovascular Society grades angina pectoris ranges from grade 1 to grade 4. Higher grade indicates worse patients' condition.

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

• Minnesota Living with Heart Failure Questionnaire

  The Minnesota Living with Heart Failure Questionnaire's score ranges from 0 to 105. Higher score indicates worse patients' condition.

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

• Kansas City Cardiomyopathy Questionnaire

  The Kansas City Cardiomyopathy Questionnaire's score ranges from 0 to 100. Higher score indicates better patients' condition.

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

Secondary Outcomes (3)

• Traditional Chinese Medicine Syndrome Score

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

• Number of angina attacks

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

• Nitroglycerin dosage

  8 weeks. If the change is not significant, it can be extended to 12 weeks.

Study Arms (4)

Qi stagnation and blood stasis type control group

PLACEBO COMPARATOR

Intervention with placebo on the Basis of optimal medical treatment

Drug: Placebo

Qi stagnation and blood stasis type experimental group

EXPERIMENTAL

Intervention with Compound Danshen Dripping Pills on the Basis of optimal medical treatment

Drug: Compound Danshen Dripping Pills

Qi deficiency and blood stasis type control group

PLACEBO COMPARATOR

Intervention with placebo on the Basis of optimal medical treatment

Drug: Placebo

Qi deficiency and blood stasis type experimental group

EXPERIMENTAL

Intervention with Qishen Yiqi Dropping Pills on the basis of conventional western medicine treatment

Drug: Qishen Yiqi Drop Pills

Interventions

Compound Danshen Dripping Pills DRUG

The experimental group used compound Danshen dripping pills as an intervention on the basis of conventional western medicine treatment.

Qi stagnation and blood stasis type experimental group

Qishen Yiqi Drop Pills DRUG

The experimental group used Qishen Yiqi dripping pills as an intervention on the basis of conventional western medicine treatment.

Qi deficiency and blood stasis type experimental group

Placebo DRUG

Intervention with placebo on the Basis of optimal medical treatment

Qi deficiency and blood stasis type control group; Qi stagnation and blood stasis type control group

Eligibility Criteria

• Age: 75 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old ≤ age \< 90 years old, regardless of gender;
• Patients who meet the diagnostic criteria for angina pectoris, including patients with typical or atypical angina pectoris: discomfort in the anterior region is triggered by physical activity or emotional excitement and can be relieved by rest or taking nitroglycerin.Those who meet two or more of the above characteristics. After receiving conventional Western medicine treatment, the symptoms did not improve significantly or the treatment effect is poor.
• Meet the diagnostic criteria for multiple coronary artery disease with the number of coronary artery disease being greater than or equal to two (defined as angiographically the right coronary artery, left circumflex artery or left anterior descending artery stenosis rate was greater than 50%), and the patient refused or could not tolerate coronary artery revascularization or one or more coronary arteries still have a stenosis rate of ≥50% after partial revascularization;
• The patient is in line with the qi stagnation and blood stasis type or qi deficiency and blood stasis type in the TCM syndrome classification. If the results of the two syndrome differentiation are inconsistent, the TCM experts will review the syndrome differentiation, and the syndrome differentiation classification of the TCM experts shall prevail.
• The patient has good communication skills, can understand and provide relevant information required for the study, and is aware of the research purpose, content, possible risks and expected benefits can be fully provided with relevant information required for this research. Patients and their families voluntarily participated and agreed to sign the informed consent.

You may not qualify if:

• Those who have had acute coronary syndrome within the past month
• Acute myocardial infarction, acute myocarditis, severe arrhythmia, aortic dissecction, pericarditis, heart failure (NYHA heart function class Ⅲ or IV, EF ≤ 30%), cardiogenic shock in past 3 months or patients with chest tightness and chest pain caused by other diseases such as severe valvular disease, etc.
• Combined with acute pulmonary embolism, acute cerebral hemorrhage, polyarteritis, severe hematologic diseases, severe infectious diseases, severe immune dysfunction, malignant tumors, other organ failure or expected life expectancy less than 1 year
• Severe primary disease or severe dysfunction of the liver or kidneys（ALT levels exceeding 3.0 times the upper limit of normal or eGFR ≤30 mL/min/1.73 m²）
• Patients with severe mental disorder
• Those who are allergic to the test drug
• Patients who have participated in other clinical trials in the past month
• Patients who have taken anticoagulants such as warfarin, new oral anticoagulants (NOAC) or traditional Chinese medicine preparations for promoting blood circulation and removing blood stasis in the past month
• Refusal to sign informed consent

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 27, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-02

Locations

CN (1)