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Coronary Artery BypassNCT06961136

Prospective Cohort Study on Fuzheng Yangxin Prescription For Rapid Rehabilitation of Patients With Qi-Yin Deficiency Syndrome After Coronary Artery Bypass Grafting

An observational study of Coronary Artery Bypass, run by Peking University Third Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial… Read more about this study

Who is it for?
Ages 25 to 85 years
Conditions the study is for
Coronary Artery Bypass
What is being tested?
Fuzheng Yangxin prescription
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteChina
Study dates
10 May 2025to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 25 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation

Who may be able to join

  • Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation

Who cannot join

  • ① Patients allergic to Fuzheng Yangxin Fang granules
  • Patients with postoperative cold and fever ③ Patients with severe postoperative hepatic and renal insufficiency ④ Other circumstances: Concurrent valvular surgery or other cardiac surgery, end-stage malignant tumor, uncontrolled infection, bleeding, progressive degenerative systemic disease, severe brain injury, multiple organ failure, other vital organ dysfunction such as severe liver impairment, severe heart failure or cardiogenic shock, inability to tolerate surgery, etc.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yichen Gong Doctor contact

8618611693463

18611693463@126.com

China1 site, 1 recruiting
  • Peking university third hospital

    Beijing, Beijing Municipality, 100191

    Recruiting

Other trials in China

About this study

Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year. Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.

Read the detailed description

Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year.

Although CABG surgery has a better long-term survival rate for patients with complex lesions, no matter what method of CABG surgery, it will inevitably cause a large blow to patients and bring a huge burden on patients' physiological and psychological functions in the early postoperative period. In the SYNTAX trial, The physiological function scores (SF-36 and EQ-5D) of the patients after CABG were significantly lower than those after PCI. Another RCT study, the FREEDOM trial, showed that although CABG had a good quality of life and physiological status 12 months after surgery, compared with PCI, CABG quality of life and psychological status scores were significantly lower at 6 months after surgery. These trials suggest that patients with CABG face an early recovery challenge due to surgical trauma. And as the number of older adults receiving CABG increases, the problem is likely to get worse. At the same time, there are many postoperative complications such as myocardial infarction, heart failure and atrial fibrillation after CABG.

Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.

If this study confirms the effectiveness and safety of Fuzheng Yangxin prescription in treating Qi-Yin deficiency syndrome after CABG operation, it can significantly improve patients' quality of life and shorten hospitalization and rehabilitation time, which can benefit more patients, significantly reduce medical costs and reduce the burden of medical insurance, and contribute to the implementation of the Healthy China strategy. At the same time, through the promotion of this project, it is expected to promote the cooperation between traditional Chinese and Western medicine after cardiac surgery, form a routine program and promote it, accelerate the transformation of intellectual property rights, and promote the construction of the "flagship" hospital of traditional Chinese and Western medicine cooperation in Peking University Third Hospital.

Being tested
Fuzheng Yangxin prescription, placebo
Keywords
Coronary Artery Bypass, Chinese herbal medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fuzheng Yangxin prescriptionDrug

    Fuzheng Yangxin prescription

  • placeboDrug

    placebo

Study groups in NCT06961136
Study groupRoleWhat they receive
Fuzheng Yangxin prescriptionNot described
Receives: Drug: Fuzheng Yangxin prescription
placeboNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAQ scores on PL

    Measured: 7days

Secondary outcomes (2)
  1. Perioperative safety index

    Measured: 14d

  2. SAQ scores on others

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start10 May 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961136
Sponsor's protocol ID
BYSY202451303
Status last verified
Feb 2026
First submitted
29 Apr 2025
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yu J, Wang Y, Li Y, Ding T, Meng L, Ma X, Ling Y, Gong Y. Efficacy, safety, and transcriptomic mechanisms of Fuzheng Yangxin formula for enhanced recovery after coronary artery bypass grafting: a propensity score-matched prospective cohort study. Front Med (Lausanne). 2026 Aug 12;13:1902379. doi: 10.3389/fmed.2026.1902379. eCollection 2026.

    PubMed 42656530

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Bypass, run by Peking University Third Hospital at 1 site 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yichen Gong Doctor (8618611693463, 18611693463@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAQ scores on PL (time frame: 7days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06961136, which also lists 1 linked publication.

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 8 May 2026.

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