Coronary Heart DiseasePhase 4NCT04270279
Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris
A Phase 4 study testing Xueshuanxinmaining tablet and Nitroglycerin tablets in people with Coronary Heart Disease and Stable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Stable Angina
- What is being tested?
- Xueshuanxinmaining tablet and Nitroglycerin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Oct 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are aged between 40 and 75 years.
- Meet the diagnostic criteria of stable angina pectoris.
- Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome.
- Voluntarily participate and sign informed consent.
Who cannot join
- Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.
- Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year.
- Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.
- Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.
- With a history of alcohol and drug abuse.
- Pregnant or lactating women.
- Patients who have participated in clinical trials of other drugs within 3 months before enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris: Multicenter, Randomised, Double Blind, Placebo Controlled Trial
This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
Read the detailed description
Xueshuanxinmaining tablet is a Chinese patent medicine composed of Ligusticum chuanxiong, Salvia miltiorrhiza, borneol and Toad puff, etc. It has been widely used in cardiovascular diseases in China. Clinical application suggested that Xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. However, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. This randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
- Conditions
- Coronary Heart Disease, Stable Angina
- Being tested
- Xueshuanxinmaining tablet, Xueshuanxinmaining placebo, Nitroglycerin tablets
- Keywords
- Coronary heart disease, Stable angina, Traditional Chinese medicine, Xueshuanxinmaining tablet
- Medical subject headings
- Coronary Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xueshuanxinmaining tabletDrug
Also called XSXMN
A kind of Chinese patent medicine
Xueshuanxinmaining placeboDrug
Also called XSXMN placebo
The simulant of Xueshuanxinmaining tablet
Nitroglycerin tabletsDrug
Be used when angina attack
| Study group | Role | What they receive |
|---|---|---|
| Xueshuanxinmaining Tablet | Experimental | Patients were given Xueshuanxinmaining tablet orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack.
For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment. Receives: Drug: Xueshuanxinmaining tablet; Drug: Nitroglycerin tablets |
| Placebo | Placebo comparator | Patients were given Xueshuanxinmaining tablet simulation orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack.
For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment. Receives: Drug: Xueshuanxinmaining placebo; Drug: Nitroglycerin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stopping or reducing rate of antianginal drugs
Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.
Measured: Eight weeks after treatment
Secondary outcomes (3)
Stopping or reducing rate of antianginal drugs
Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.
Measured: Two, four and eight weeks after treatment
Changes of electrocardiogram (ECG)
Mainly observe the ST segment and the change of T wave from the baseline
Measured: Four and eight weeks after treatment
Changes of Seattle Angina Questionnaire scores (SAQ scores)
The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. higher scores mean a better outcome.
Measured: Four and eight weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jun Li, MD, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270279
- Sponsor's protocol ID
- XSXMN_2019001
- Status last verified
- Nov 2020
- First submitted
- 12 Feb 2020
- Last updated
- 13 Nov 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris: Multicenter, Randomised, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04270279
- Acronym / sponsor ID
- XSXMN_2019001
- Conditions
- Coronary Heart Disease, Stable Angina
- Keywords
- Coronary heart disease, Stable angina, Traditional Chinese medicine, Xueshuanxinmaining tablet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 Feb 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.
This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
Detailed description
Xueshuanxinmaining tablet is a Chinese patent medicine composed of Ligusticum chuanxiong, Salvia miltiorrhiza, borneol and Toad puff, etc. It has been widely used in cardiovascular diseases in China. Clinical application suggested that Xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. However, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. This randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
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 |
|---|---|---|
| Xueshuanxinmaining Tablet | Experimental | Drug: Xueshuanxinmaining tablet, Drug: Nitroglycerin tabletsPatients were given Xueshuanxinmaining tablet orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment. |
| Placebo | Placebo comparator | Drug: Xueshuanxinmaining placebo, Drug: Nitroglycerin tabletsPatients were given Xueshuanxinmaining tablet simulation orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants are aged between 40 and 75 years.
- Meet the diagnostic criteria of stable angina pectoris.
- Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome.
- Voluntarily participate and sign informed consent.
Key exclusion criteria (7 listed)
- Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.
- Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year.
- Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.
- Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.
- With a history of alcohol and drug abuse.
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 |
|---|---|---|
| Xueshuanxinmaining tabletAlso: XSXMNA kind of Chinese patent medicine | Drug | Xueshuanxinmaining Tablet |
| Xueshuanxinmaining placeboAlso: XSXMN placeboThe simulant of Xueshuanxinmaining tablet | Drug | Placebo |
| Nitroglycerin tabletsBe used when angina attack | Drug | Placebo, Xueshuanxinmaining Tablet |
Primary outcome
Stopping or reducing rate of antianginal drugs
Time frame: Eight weeks after treatment
Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.
3 secondary outcomes
Stopping or reducing rate of antianginal drugs
Time frame: Two, four and eight weeks after treatment
Changes of electrocardiogram (ECG)
Time frame: Four and eight weeks after treatment
Changes of Seattle Angina Questionnaire scores (SAQ scores)
Time frame: Four and eight weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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.
Jun Li, MD study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xueshuanxinmaining tablet and Nitroglycerin tablets in people with Coronary Heart Disease and Stable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 4 inclusion and 7 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Li, MD (+86 13051458913, gamyylj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stopping or reducing rate of antianginal drugs (time frame: Eight weeks after 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 13 Nov 2020.