HuoXin Pills for improving heart health after balloon surgery
Prospective, Randomized, Double-blind, Placebo-controlled Clinical Study of Yuekang Huoxin Pill (Concentrated Pill) Intervening in the Prognosis of Patients With Coronary Heart Disease After Drug-Coated Balloon Implantation With Qi Deficiency and Blood Stasis Syndrome
This study is testing if taking Huoxin Pills can help people with coronary heart disease feel better and have fewer heart problems after balloon surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT05489016 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, randomized, double-blind, placebo-controlled study that evaluates the effectiveness of Huoxin Pills, a traditional Chinese medicine, in improving the prognosis of patients with coronary heart disease following drug-coated balloon implantation. The study involves 440 patients who will be monitored for one year to assess various outcomes, including blood flow scores, late lumen loss, and the incidence of major adverse cardiac events (MACE). The trial aims to explore how combining Huoxin Pills with drug-coated balloon therapy can reduce vascular restenosis and improve patient outcomes after percutaneous coronary intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with coronary heart disease and have undergone drug-coated balloon surgery within the last two weeks.
Not a fit: Patients with severe arrhythmias, significant organ dysfunction, or other serious cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option to enhance recovery and reduce complications for patients undergoing coronary interventions.
How similar studies have performed: Previous studies have indicated that traditional Chinese medicine can effectively reduce restenosis rates and improve cardiovascular outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing and 2 other locations
- Fuwai Hospital, China National Center for Cardiovascular Diseases — Beijing, Beijing, China (Recruiting)
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Fuwai Yunnan Cardiovascular Hospital — Kunming, Yunnan, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Jie Ma, MD
- Email: doctorsuleyman@163.com
- Phone: +86(010)88398168
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.