HuoXin Pills Intervention on Patients With Coronary Heart Disease After Drug-Coated Balloon Implantation (HAPPY-DCB)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Heart Disease; Medicine, Chinese Traditional
• Intervention / Treatment: Drug: Yuekang Huoxin Pills (concentrated pills); Drug: Yuekang Huoxin Pills (concentrated pills)simulant

Detailed Description

Percutaneous coronary intervention (PCI) is currently the main treatment for coronary heart disease. Drug-coated balloon (DCB) is an emerging interventional therapy technology. DCB can effectively reduce the incidence of vascular restenosis and cardiovascular composite event endpoints after PCI. However, the incidence of target lesion failure and major adverse cardiac event (MACE) of DCB in the treatment of primary coronary artery disease within one year after surgery can also reach more than 10%. Therefore, how to reduce vascular restenosis after DCB and other related cardiovascular composite endpoint events through the combination of DCB and drug therapy is a potential development direction of existing DCB therapy.

The research results of Chinese scholars have shown that the traditional Chinese medicine of replenishing qi and activating blood circulation can significantly reduce the restenosis rate after PCI, the recurrence rate of angina pectoris and the incidence of cardiovascular composite endpoint in three and six months after PCI.

It has significant clinical efficacy in improving the symptoms and prognosis of patients with coronary heart disease such as angina pectoris. In addition, basic research has further shown that Huoxin Pill (concentrated pill) can significantly reduce the degree and scope of myocardial ischemia and has the effects of dilating coronary artery and improving microcirculation.

Quantitative flow fraction (QFR) technology is the new method with the most sufficient clinical evidence in recent years, and can rapidly calculate the coronary stenosis-related lesions and severity of the diseased vessels in real time during the operation. Therefore, in this study, the QFR technology was used to evaluate the postoperative efficacy of DCB and the combination of Huoxin Pill (concentrated pill).

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.

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jie Ma, MD; Phone Number: +86(010)88398168; Email: doctorsuleyman@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital, China National Center for Cardiovascular Diseases
      • Contact: Lei Yan; Phone Number: +86(010)88396282; Email: fuwailunli@fuwai.com
      • Principal Investigator: Lihong Ma, MD
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Fuwai Central China Cardiovascular Hospital
      • Principal Investigator: Muwei Li, MD
      • Contact: Muwei Li, MD; Phone Number: +86(0371)87160980; Email: kyc65580059@163.com
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Not yet recruiting
      • Fuwai Yunnan Cardiovascular Hospital
      • Contact: Mingyue Chen; Phone Number: +86(0371)58680175; Email: hzfwllwyh@163.com
      • Principal Investigator: Jie Bai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yuekang Huoxin Pills (concentrated pills); 2 pills at a time, 3 times a day	Drug: Yuekang Huoxin Pills (concentrated pills); Huoxin Pill (concentrated pill) is composed of Radix Ginseng, Radix Aconiti Lateralis Preparata, Ganoderma, Flos Carthami, artificial Moschus, cultured calculus bovis in vitro, Fel Ursi, Margarita, Venenum Bufonis, and Borneolum Syntheticum. It has the effect of invigorating qi and promoting blood circulation. It has been marketed in China for more than 30 years. Clinical studies have shown that Huoxin Pill (concentrated pill) has significant clinical efficacy in improving the symptoms and prognosis of coronary heart disease and angina pectoris. Basic studies have also confirmed that Huoxin Pill (concentrated pill) can play a role in myocardial protection by dilating coronary arteries and promoting angiogenesis. It produced by Guangzhou yuekang biopharmaceuticals co., ltd.
Placebo Comparator: Yuekang Huoxin Pills (concentrated pills) simulant; 2 pills at a time, 3 times a day	Drug: Yuekang Huoxin Pills (concentrated pills)simulant; Huoxin Pill (concentrated pill) simulant, a placebo-like simulation have no therapeutic effect. The shape, packaging and taste are the same as Huoxin Pill (concentrated pill), produced by Guangzhou yuekang biopharmaceuticals co., ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QFR	quantitative flow fraction was measured by coronary angiography at 12-month follow-up. The AngioPlus system (Pulse Medical Imaging Technology, Shanghai Co., Ltd., Shanghai, China) is used for computation of QFR in this trial. n order to obtain accurate QFR measurement, analysts are required to follow the SOP (Standard Operation Procedure) for angiographic image acquisition.	At the end of the 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QFR change value	quantitative flow fraction change value was measured by coronary angiography in 12-month Drug intervention. The AngioPlus system (Pulse Medical Imaging Technology, Shanghai Co., Ltd., Shanghai, China) is used for computation of QFR in this trial. n order to obtain accurate QFR measurement, analysts are required to follow the SOP (Standard Operation Procedure) for angiographic image acquisition.	At the end of the 12-month follow-up
Late Lumen Loss Late lume loss	The software was used to automatically profile the artery by subtracting the minimum lumen diameter at the 12-month follow-up from the minimum lumen diameter immediately after coronary angiography within the drug-coating balloon.	At the end of the 12-month follow-up
incidence of main adverse cardiac events composite endpoints incidence of cardiovascular composite endpoints	the occurrence of death, myocardial infarction and revascularization	At the end of the 12-month follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): July 13, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Heart Disease; Medicine, Chinese Traditional; Drug-coated balloon; Quantitative flow ratio
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2021-1467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No