HuoXin Pills Intervention on Patients With Coronary Heart Disease After Drug-Coated Balloon Implantation

• Status: Not yet recruiting
• Trial end date: 2025-07-13
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a multi-center, randomized, double-blind, placebo, parallel controlled study. Objectively evaluates the curative effect of Huoxin Pills (concentrated pills) intervention on improving the prognosis of patients with coronary heart disease after drug-coated balloon implantation from a functional point of view. Huoxin Pill(concentrated pills), a traditional Chinese medicine, has been prescribed widely in the treatment of coronary heart disease, angina pectoris, and other diseases.440 patients were selected and followed up for one year. The quantitative blood flow score of the target vessel, late lumen loss, MACE incidence, and safety index were observed at 12 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Fuwai Central China Cardiovascular Hospital; Fuwai Yunnan Cardiovascular Hospital

Criteria

Inclusion Criteria:

1. Aged 18-75 years;

2. Patients who meet the diagnostic criteria of Western medicine for coronary heart disease, elective patients within two weeks after DCB surgery;

3. Voluntary selection of patients who undergo coronary angiography 12 months after surgery;

4. Meet the TCM criteria for syndrome differentiation of Qi deficiency and blood stasis (total score >= 8 points, and secondary symptoms >= 4 points);

5. The patients voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria:

1. Severe arrhythmia, severe cardiopulmonary insufficiency and poorly controlled hypertension;

2. Patients with serious primary diseases such as severe liver and kidney damage, hematopoietic system, and mental illness;

3. Patients with heart valve disease, cardiomyopathy, congenital heart disease, aortic dissection or aortic aneurysm that need to be corrected by surgery or interventional therapy;

4. Those who have cerebrovascular events such as stroke and transient cerebral ischemia within 6 months;

5. Pregnant, planning pregnancy or lactating patients;

6. Allergic constitution and those who are allergic to known components of the research drug;

7. Those who are participating in other clinical trials or have participated in other drug clinical trials within one month;

8. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.