Adding Compound Danshen and Qishen Yiqi pills for older adults with ongoing angina after standard heart treatment
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
This study will test whether adding two traditional Chinese medicine pills (Compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill) helps people aged 75–89 who still have angina after standard medical treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 75 Years to 90 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07041359 on ClinicalTrials.gov |
What this trial studies
This is a prospective, double-blind, randomized controlled trial enrolling patients aged 75 to 89 with stable angina and multi-vessel coronary artery disease who remain symptomatic despite optimal Western medical therapy. Participants are randomized to receive Compound Danshen Dripping Pills, Qishen Yiqi Dripping Pills, or placebo in addition to their regular cardiac medications. The protocol tracks angina symptoms, safety outcomes related to multiple medications, and standard cardiovascular measures over the treatment period. The design combines guideline-directed Western therapy with traditional Chinese medicine to evaluate both efficacy and tolerability in a frail, elderly population.
Who should consider this trial
Good fit: Ideal candidates are people aged 75–89 with stable angina and angiographic evidence of two or more coronary artery stenoses (≥50%) who remain symptomatic despite conventional medical treatment and who have declined or cannot tolerate revascularization.
Not a fit: Patients younger than 75, those without multi-vessel disease, those who have already had successful revascularization, or those with conditions preventing TCM use are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, the combination could reduce angina symptoms and offer a tolerable adjunct to standard care for elderly patients who cannot have or remain symptomatic after revascularization.
How similar studies have performed: Previous studies have reported efficacy and safety signals for each of these traditional Chinese medicine preparations individually, but combining them as polypharmacy in an elderly population is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 75 years old ≤ age \< 90 years old, regardless of gender; 2. 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. 3. 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; 4. 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. 5. 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. Exclusion Criteria: 1. Those who have had acute coronary syndrome within the past month 2. 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. 3. 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 4. 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） 5. Patients with severe mental disorder 6. Those who are allergic to the test drug 7. Patients who have participated in other clinical trials in the past month 8. 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 9. Refusal to sign informed consent
Where this trial is running
Beijing, Beijing Municipality
- Fuwai hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.