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

NCT05489016 | Unknown Phase 4 DMC

• 1 other identifier: 2021-1467
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Coronary Heart Disease; Medicine, Chinese Traditional

Keywords

Coronary Heart Disease; Medicine, Chinese Traditional; Drug-coated balloon; Quantitative flow ratio

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• QFR change value

  At the end of the 12-month follow-up

• Late Lumen Loss Late lume loss

  At the end of the 12-month follow-up

• incidence of main adverse cardiac events composite endpoints incidence of cardiovascular composite endpoints

  At the end of the 12-month follow-up

Study Arms (2)

Yuekang Huoxin Pills (concentrated pills)

EXPERIMENTAL

2 pills at a time, 3 times a day

Drug: Yuekang Huoxin Pills (concentrated pills)

Yuekang Huoxin Pills (concentrated pills) simulant

PLACEBO COMPARATOR

2 pills at a time, 3 times a day

Drug: Yuekang Huoxin Pills (concentrated pills)simulant

Interventions

Yuekang Huoxin Pills (concentrated pills) DRUG

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.

Yuekang Huoxin Pills (concentrated pills)

Yuekang Huoxin Pills (concentrated pills)simulant DRUG

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.

Yuekang Huoxin Pills (concentrated pills) simulant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years;
• Patients who meet the diagnostic criteria of Western medicine for coronary heart disease, elective patients within two weeks after DCB surgery;
• Voluntary selection of patients who undergo coronary angiography 12 months after surgery;
• Meet the TCM criteria for syndrome differentiation of Qi deficiency and blood stasis (total score \>= 8 points, and secondary symptoms \>= 4 points);
• The patients voluntarily participated in the trial and signed the informed consent.

You may not qualify if:

• Severe arrhythmia, severe cardiopulmonary insufficiency and poorly controlled hypertension;
• Patients with serious primary diseases such as severe liver and kidney damage, hematopoietic system, and mental illness;
• Patients with heart valve disease, cardiomyopathy, congenital heart disease, aortic dissection or aortic aneurysm that need to be corrected by surgery or interventional therapy;
• Those who have cerebrovascular events such as stroke and transient cerebral ischemia within 6 months;
• Pregnant, planning pregnancy or lactating patients;
• Allergic constitution and those who are allergic to known components of the research drug;
• Those who are participating in other clinical trials or have participated in other drug clinical trials within one month;
• Those who are judged by the investigator to be unsuitable to participate in this clinical trial.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (3)

Fuwai Hospital, China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, 650000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Jie Ma, MD

CONTACT

+86(010)88398168; doctorsuleyman@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Traditional Chinese Medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 5, 2022
• Study Start: August 5, 2022
• Primary Completion: January 1, 2024
• Study Completion: July 13, 2025
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)