Stable Coronary Heart DiseasePhase 4NCT04421287
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD
A Phase 4 study testing Zhenyuan capsule in people with Stable Coronary Heart Disease, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stable Coronary Heart Disease
- What is being tested?
- Zhenyuan capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Dec 2021
- 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
- Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
- LVEF≥40%；
- Angina grade Ⅰ-Ⅱ (CCS grade);
- The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
- 18 years old ≤ age ≤ 75 years old；
- In accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise；
- Those who sign the informed consent form.
Who cannot join
- Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
- Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
- Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
- Renal insufficiency, serum creatinine > 2.5mg / dl in male and > 2.0mg/dl in female；
- Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
- New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
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- Complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection;
- Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥ 9.5%;
- Pregnant or preparing pregnant women, lactating women;
- Patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness;
- For those who are allergic to the known ingredients of the drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, 100091
long C Wang, doctorate, 0086-010-6287 ext. 9814, WCL796@163.com
About this study
Official title: Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With Stable Coronary Heart Disease With Qi Deficiency and Blood Stasis
A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.
- Conditions
- Stable Coronary Heart Disease
- Being tested
- Zhenyuan capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zhenyuan capsuleDrug
0.25g/ tablets, 2 tablets / TID, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Zhenyuan capsule | Experimental | Not described Receives: Drug: Zhenyuan capsule |
| Zhenyuan capsule placebo | Placebo comparator | Not described Receives: Drug: Zhenyuan capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary function index change
Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；
Measured: Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long C Wang, doctorate, Study chair, Xiyaun Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421287
- Sponsor's protocol ID
- 2020XLA018-2
- Status last verified
- Apr 2020
- First submitted
- 6 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With Stable Coronary Heart Disease With Qi Deficiency and Blood Stasis
- ClinicalTrials.gov ID
- NCT04421287
- Acronym / sponsor ID
- 2020XLA018-2
- Conditions
- Stable Coronary Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Jun 2020 (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.
A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zhenyuan capsule | Experimental | Drug: Zhenyuan capsule |
| Zhenyuan capsule placebo | Placebo comparator | Drug: Zhenyuan capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
- LVEF≥40%；
- Angina grade Ⅰ-Ⅱ (CCS grade);
- The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
- 18 years old ≤ age ≤ 75 years old；
Key exclusion criteria (11 listed)
- Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
- Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
- Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
- Renal insufficiency, serum creatinine > 2.5mg / dl in male and > 2.0mg/dl in female；
- Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
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 |
|---|---|---|
| Zhenyuan capsule0.25g/ tablets, 2 tablets / TID, for 12 weeks | Drug | Zhenyuan capsule, Zhenyuan capsule placebo |
Primary outcome
Cardiopulmonary function index change
Time frame: Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;
Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
Long C Wang, doctorate study chair
Xiyaun Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zhenyuan capsule in people with Stable Coronary Heart Disease, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences 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 7 inclusion and 11 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 9 Jun 2020. 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. 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 NA HUAN, Master (0086 ext. 18353214796, HUANNA0323@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary function index change (time frame: Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;). 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 9 Jun 2020.