Chronic Stable AnginaNCT06224582
Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI
A study testing Yinxingmihuan oral solution in people with Chronic Stable Angina, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Yinxingmihuan oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2020to 25 Dec 2023
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female aged 18-85 years;
- patients with a history of percutaneous coronary intervention for coronary heart disease for more than 30 days and less than 180 days, without need of further elective coronary revascularization (PCI, CABG) judged by cardiovascular specialists;
- patients with symptoms such as chest distress, chest pain, palpitation, pain in shoulder and back, shortness of breath, weakness, activity intolerance, etc. Angina frequency (AF) score in Seattle Angina Questionnaire (SAQ) no more than 80;
- Hamilton Anxiety Scale score between 7 and 21 (mild to moderate anxiety);
- written informed consent.
Who cannot join
- women who are pregnant or preparing to be pregnant or nursing, menstruating women;
- women of child-bearing age who do not agree to use contraception during the medication phase;
- patients with severe anxiety (Hamilton Anxiety Scale score more than 21);
- patients with severe depression (Hamilton Depression Scale score not less than 24);
- patients who are currently taking anti-anxiety drug;
- participants with stable angina classified into Canadian Cardiovascular Society (CCS) Grade 4;
Show all 22Show fewer
- uncontrolled hypertension (systolic > 180 mmHg or diastolic > 100 mmHg) despite using ongoing antihypertensive treatment;
- heart failure assessed by New York Heart Association (NYHA);
- patients with coronary heart disease and atrial fibrillation;
- clinically significant complications, including liver dysfunction (ALT or AST level more than 2 times higher than normal), renal dysfunction (serum creatinine level more than 2 times higher than normal), severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage or epilepsy, with need of anticonvulsant drugs;
- within 7 days of introduction period, patients who no longer have angina-related symptoms;
- within the three months before start of the study, patients with myocardial infarction or CCS 4 angina;
- patients with acute coronary syndrome confirmed by examinations and other chest pain caused by rheumatic heart disease, dilated cardiomyopathy, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, bilio-cardiac syndrome, gastroesophageal reflux, hiatal hernia, aortic dissection, pulmonary embolism, mediastinal hematoma, etc;
- history of specific bleeding or bleeding caused by warfarin;
- patients with previous hematopoietic diseases;
- patients who have undergone surgery (not including PCI) within the last 4 weeks and are prone to bleeding;
- patients who participate in any other clinical study or take any other investigational drug within 90 days;
- patients who are known or suspected to be allergic to the drug in this study or are allergic constitution;
- drug abusers who have a history of alcohol abuse or drug dependence in the past 2 years;
- psychopath;
- patients who have been judged by their doctors to be ineligible for the study;
- patient who is a family member or relative of the staff working in the centers.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
Beijing, 100037
About this study
Official title: Efficacy and Safety of Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled Study
A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.
- Conditions
- Chronic Stable Angina
- Being tested
- Yinxingmihuan oral solution, Placebo
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yinxingmihuan oral solutionDrug
Also called Ginkgo leaf extract and armillariella mellea powders
Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.
PlaceboDrug
The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.
| Study group | Role | What they receive |
|---|---|---|
| Yinxingmihuan group | Experimental | standardized medical treatment regimen plus Yinxingmihuan oral solution (oral, 10 ml once, 3 times a day) Receives: Drug: Yinxingmihuan oral solution |
| Placebo group | Placebo comparator | standardized medical treatment regimen plus Placebo oral solution (oral, 10 ml once, 3 times a day) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAQ-angina frequency
angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)
Measured: at 12-week follow-up
Secondary outcomes (9)
HAMA improvement
variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline
Measured: at 12-week follow-up
CCS grade
angina grade assessed by Canadian Cardiovascular Society (CCS)
Measured: before randomization, in 4,8,12,16 and 20 weeks
NYHA class
heart function assessed by New York Heart Association (NYHA)
Measured: before randomization, in 4,8,12,16 and 20 weeks
VAS
generic health status assessed by visual analogue scale (VAS)
Measured: before randomization, in 4,8,12,16 and 20 weeks
HAMA reductive ratio
variation of Hamilton Anxiety Scale (HAMA) score at 12-week follow-up compared with baseline divided by the baseline value
Measured: at 12-week follow-up
HAMD depression score
proportion of participants with improvement or disappear of depression according to Hamilton Depression Scale (HAMD)
Measured: before randomization, in 4,8,12,16 and 20 weeks
weekly angina frequency
weekly angina frequency recorded by the participants' diary cards
Measured: before randomization, in 4,8,12,16 and 20 weeks
SF-12 score
generic health status measured by 12-Item Short Form Health Survey (SF-12)
Measured: before randomization, in 4,8,12,16 and 20 weeks
Nitroglycerin discontinuation rate
proportion of participants that no longer need any nitroglycerin medications
Measured: before randomization, in 4,8,12,16 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start30 Dec 2020
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224582
- Sponsor's protocol ID
- Yinxingmihuan01
- Status last verified
- Mar 2021
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06224582
- Acronym / sponsor ID
- Yinxingmihuan01
- Conditions
- Chronic Stable Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 25 Jan 2024 (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 prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yinxingmihuan group | Experimental | Drug: Yinxingmihuan oral solutionstandardized medical treatment regimen plus Yinxingmihuan oral solution (oral, 10 ml once, 3 times a day) |
| Placebo group | Placebo comparator | Drug: Placebostandardized medical treatment regimen plus Placebo oral solution (oral, 10 ml once, 3 times a day) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female aged 18-85 years;
- patients with a history of percutaneous coronary intervention for coronary heart disease for more than 30 days and less than 180 days, without need of further elective coronary revascularization (PCI, CABG) judged by cardiovascular specialists;
- patients with symptoms such as chest distress, chest pain, palpitation, pain in shoulder and back, shortness of breath, weakness, activity intolerance, etc. Angina frequency (AF) score in Seattle Angina Questionnaire (SAQ) no more than 80;
- Hamilton Anxiety Scale score between 7 and 21 (mild to moderate anxiety);
- written informed consent.
Key exclusion criteria (22 listed)
- women who are pregnant or preparing to be pregnant or nursing, menstruating women;
- women of child-bearing age who do not agree to use contraception during the medication phase;
- patients with severe anxiety (Hamilton Anxiety Scale score more than 21);
- patients with severe depression (Hamilton Depression Scale score not less than 24);
- patients who are currently taking anti-anxiety drug;
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 |
|---|---|---|
| Yinxingmihuan oral solutionAlso: Ginkgo leaf extract and armillariella mellea powdersYinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders. | Drug | Yinxingmihuan group |
| PlaceboThe placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution. | Drug | Placebo group |
Primary outcome
SAQ-angina frequency
Time frame: at 12-week follow-up
angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)
9 secondary outcomes
HAMA improvement
Time frame: at 12-week follow-up
CCS grade
Time frame: before randomization, in 4,8,12,16 and 20 weeks
NYHA class
Time frame: before randomization, in 4,8,12,16 and 20 weeks
VAS
Time frame: before randomization, in 4,8,12,16 and 20 weeks
HAMA reductive ratio
Time frame: at 12-week follow-up
HAMD depression score
Time frame: before randomization, in 4,8,12,16 and 20 weeks
weekly angina frequency
Time frame: before randomization, in 4,8,12,16 and 20 weeks
SF-12 score
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Nitroglycerin discontinuation rate
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Related trials for Chronic Stable Angina
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
RecruitingObservational study
Barts Revascularisation Registry
Myocardial Infarction, Stable Angina
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yinxingmihuan oral solution in people with Chronic Stable Angina, run by China National Center for Cardiovascular Diseases 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 5 inclusion and 22 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: finished, as of the sponsor's last update on 25 Jan 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAQ-angina frequency (time frame: at 12-week 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 25 Jan 2024.