Adding Compound Danshen and Qishen Yiqi pills for older adults with ongoing angina after standard heart treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fuwai hospital, CAMS&PUMC
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.