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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 25, 2022
First Posted Date  ICMJE August 5, 2022
Last Update Posted Date August 17, 2022
Actual Study Start Date  ICMJE August 5, 2022
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2022)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2022)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HuoXin Pills Intervention on Patients With Coronary Heart Disease After Drug-Coated Balloon Implantation
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Heart Disease
  • Medicine, Chinese Traditional
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Yuekang Huoxin Pills (concentrated pills)
    2 pills at a time, 3 times a day
    Intervention: Drug: Yuekang Huoxin Pills (concentrated pills)
  • Placebo Comparator: Yuekang Huoxin Pills (concentrated pills) simulant
    2 pills at a time, 3 times a day
    Intervention: Drug: Yuekang Huoxin Pills (concentrated pills)simulant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2022)		 440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 13, 2025
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jie Ma, MD +86(010)88398168 doctorsuleyman@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05489016
Other Study ID Numbers  ICMJE 2021-1467
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Lihong Ma, China National Center for Cardiovascular Diseases
Original Responsible Party Same as current
Current Study Sponsor  ICMJE China National Center for Cardiovascular Diseases
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fuwai Yunnan Cardiovascular Hospital
Investigators  ICMJE Not Provided
PRS Account China National Center for Cardiovascular Diseases
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP