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

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ClinicalTrials.gov Identifier: NCT05489016
Recruitment Status : Recruiting
First Posted : August 5, 2022
Last Update Posted : August 17, 2022
Sponsor:
Collaborator:
Fuwai Yunnan Cardiovascular Hospital
Information provided by (Responsible Party):
Lihong Ma, China National Center for Cardiovascular Diseases

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Medicine, Chinese Traditional Drug: Yuekang Huoxin Pills (concentrated pills) Drug: Yuekang Huoxin Pills (concentrated pills)simulant Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : July 13, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. QFR [ Time Frame: At the end of the 12-month follow-up ]
    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.


Secondary Outcome Measures :
  1. QFR change value [ Time Frame: At the end of the 12-month follow-up ]
    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.

  2. Late Lumen Loss Late lume loss [ Time Frame: At the end of the 12-month follow-up ]
    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.

  3. incidence of main adverse cardiac events composite endpoints incidence of cardiovascular composite endpoints [ Time Frame: At the end of the 12-month follow-up ]
    the occurrence of death, myocardial infarction and revascularization


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05489016


Contacts
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Contact: Jie Ma, MD +86(010)88398168 doctorsuleyman@163.com

Locations
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China, Beijing
Fuwai Hospital, China National Center for Cardiovascular Diseases Recruiting
Beijing, Beijing, China, 100037
Contact: Lei Yan    +86(010)88396282    fuwailunli@fuwai.com   
Principal Investigator: Lihong Ma, MD         
China, Henan
Fuwai Central China Cardiovascular Hospital Not yet recruiting
Zhengzhou, Henan, China, 450000
Contact: Muwei Li, MD    +86(0371)87160980    kyc65580059@163.com   
Principal Investigator: Muwei Li, MD         
China, Yunnan
Fuwai Yunnan Cardiovascular Hospital Not yet recruiting
Kunming, Yunnan, China, 650000
Contact: Mingyue Chen    +86(0371)58680175    hzfwllwyh@163.com   
Principal Investigator: Jie Bai, MD         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Fuwai Yunnan Cardiovascular Hospital
More Information
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Responsible Party: Lihong Ma, Director of Department of Traditional Chinese Medicine, Principal Investigator, Clinical Professor, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT05489016    
Other Study ID Numbers: 2021-1467
First Posted: August 5, 2022    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lihong Ma, China National Center for Cardiovascular Diseases:
Coronary Heart Disease
Medicine, Chinese Traditional
Drug-coated balloon
Quantitative flow ratio
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases