Coronary Heart DiseasePhase 4HAPPY-DCBNCT05489016
HuoXin Pills Intervention on Patients With Coronary Heart Disease After Drug-Coated Balloon Implantation
A Phase 4 study testing Yuekang Huoxin Pills (concentrated pills) and Yuekang Huoxin Pills (concentrated pills)simulant in people with Coronary Heart Disease and Medicine, Chinese Traditional, run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Medicine, Chinese Traditional
- What is being tested?
- Yuekang Huoxin Pills (concentrated pills) and Yuekang Huoxin Pills (concentrated pills)simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2022to 13 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Fuwai Hospital, China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Lei Yan, +86(010)88396282, fuwailunli@fuwai.com
Lihong Ma, MD
- Not yet recruiting
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, 650000
Mingyue Chen, +86(0371)58680175, hzfwllwyh@163.com
Jie Bai, MD
- Not yet recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Muwei Li, MD, +86(0371)87160980, kyc65580059@163.com
Muwei Li, MD
About this study
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
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.
Read the 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.
- Being tested
- Yuekang Huoxin Pills (concentrated pills), Yuekang Huoxin Pills (concentrated pills)simulant
- Keywords
- Coronary Heart Disease, Medicine, Chinese Traditional, Drug-coated balloon, Quantitative flow ratio
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)simulantDrug
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 group | Role | What they receive |
|---|---|---|
| Yuekang Huoxin Pills (concentrated pills) | Experimental | 2 pills at a time, 3 times a day Receives: Drug: Yuekang Huoxin Pills (concentrated pills) |
| Yuekang Huoxin Pills (concentrated pills) simulant | Placebo comparator | 2 pills at a time, 3 times a day Receives: Drug: Yuekang Huoxin Pills (concentrated pills)simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 12-month follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: At the end of the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start5 Aug 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion13 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Fuwai Yunnan Cardiovascular Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Lihong Ma, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489016
- Sponsor's protocol ID
- 2021-1467
- Acronym
- HAPPY-DCB
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05489016
- Acronym / sponsor ID
- HAPPY-DCB / 2021-1467
- Keywords
- Coronary Heart Disease, Medicine, Chinese Traditional, Drug-coated balloon, Quantitative flow ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Fuwai Yunnan Cardiovascular Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 13 Jul 2025 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yuekang Huoxin Pills (concentrated pills) | Experimental | Drug: Yuekang Huoxin Pills (concentrated pills)2 pills at a time, 3 times a day |
| Yuekang Huoxin Pills (concentrated pills) simulant | Placebo comparator | Drug: Yuekang Huoxin Pills (concentrated pills)simulant2 pills at a time, 3 times a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| Yuekang Huoxin Pills (concentrated pills)simulantHuoxin 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. | Drug | Yuekang Huoxin Pills (concentrated pills) simulant |
Primary outcome
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.
3 secondary outcomes
QFR change value
Time frame: At the end of the 12-month follow-up
Late Lumen Loss Late lume loss
Time frame: At the end of the 12-month follow-up
incidence of main adverse cardiac events composite endpoints incidence of cardiovascular composite endpoints
Time frame: At the end of the 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yuekang Huoxin Pills (concentrated pills) and Yuekang Huoxin Pills (concentrated pills)simulant in people with Coronary Heart Disease and Medicine, Chinese Traditional, run by China National Center for Cardiovascular Diseases at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Ma, MD (+86(010)88398168, doctorsuleyman@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QFR (time frame: At the end of the 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.