Angina PectorisPhase 4NCT04984954
Evaluate the Efficacy and Safety of MUSK Pill on Coronary Microvascular Dysfunction
A Phase 4 study testing MUSK pill in people with Angina Pectoris and Coronary Heart Disease, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.
Trial summary
Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina
- What is being tested?
- MUSK pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2021to 30 Jun 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80, male or female;
- Selective coronary angiography or coronary CTA showed that the diameter of coronary artery ≥ 2.5mm, the degree of stenosis < 50%, without myocardial bridge;
- They were able to perform treadmill exercise, and the treadmill test (EET) was positive;
- Angina pectoris was found;
- Patients are willing to follow up and sign informed consent; All the above criteria should be met.
Who cannot join
- Coronary heart disease complicated with hypertrophic cardiomyopathy;
- There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;
- Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);
- Mental disorders and mental diseases;
- Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;
- Contraindications of Shexiang Baoxin Pill: forbidden for pregnant women;
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- Those who have known history of allergy to Shexiang Baoxin Pills;
- Recently, the patient has taken Shexiang Baoxin Pill and other anti ischemic traditional Chinese medicine regularly, or it contains borneol, toad venom and other ingredients in Shexiang Baoxin Pill;
- Combined with frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation, sinoatrial block, atrioventricular pathway block, left bundle branch block and right bundle branch block, which may affect the judgment of exercise ECG results;
- Researchers think that there are other factors that are not suitable to participate in the trial; If one of the exclusion criteria is met, it can be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Haiming Shi, doctor, +8613801731588, 13901824859@163.com
Ying Shan, doctor, +8613402021699, shanyingli@yahoo.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shexiang Baoxin Pill on Coronary Microvascular Dysfunction
Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality of life were also observed.
- Conditions
- Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina, Non Obstructive Coronary Artery Disease
- Being tested
- MUSK pill
- Keywords
- Shexiang Baoxin Pill, Musk pill, Patients with coronary microvascular dysfunction
- Medical subject headings
- Angina Pectoris, Coronary Disease, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUSK pillDrug
Also called Placebo
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up Receives: Drug: MUSK pill |
| Placebo group | Placebo comparator | The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up. Receives: Drug: MUSK pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference of HRR between the experimental group and the placebo group was significant
Definition of abnormal heart rate recovery: peak HR during exercise - HR one minute into recovery at the end of exercise is defined as abnormal heart rate recovery when HR one minute into recovery is less than 12 beats / min.
Measured: At the end of treatment (8 weeks (± 1 week))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start28 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- Model description
- 1:1 stratified block random grouping according to the center
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HaiMing Shi, doctor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984954
- Sponsor's protocol ID
- HMPE202001
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shexiang Baoxin Pill on Coronary Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT04984954
- Acronym / sponsor ID
- HMPE202001
- Conditions
- Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina, Non Obstructive Coronary Artery Disease
- Keywords
- Shexiang Baoxin Pill, Musk pill, Patients with coronary microvascular dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Aug 2021 (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.
Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality of life were also observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 stratified block random grouping according to the center
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: MUSK pillThis is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up |
| Placebo group | Placebo comparator | Drug: MUSK pillThe control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-80, male or female;
- Selective coronary angiography or coronary CTA showed that the diameter of coronary artery ≥ 2.5mm, the degree of stenosis < 50%, without myocardial bridge;
- They were able to perform treadmill exercise, and the treadmill test (EET) was positive;
- Angina pectoris was found;
- Patients are willing to follow up and sign informed consent; All the above criteria should be met.
Key exclusion criteria (10 listed)
- Coronary heart disease complicated with hypertrophic cardiomyopathy;
- There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;
- Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);
- Mental disorders and mental diseases;
- Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;
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 |
|---|---|---|
| MUSK pillAlso: PlaceboThis is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up | Drug | Experimental group, Placebo group |
Primary outcome
the difference of HRR between the experimental group and the placebo group was significant
Time frame: At the end of treatment (8 weeks (± 1 week))
Definition of abnormal heart rate recovery: peak HR during exercise - HR one minute into recovery at the end of exercise is defined as abnormal heart rate recovery when HR one minute into recovery is less than 12 beats / min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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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.
HaiMing Shi, doctor principal investigator
Huashan Hospital
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 MUSK pill in people with Angina Pectoris and Coronary Heart Disease, run by Shanghai Hutchison Pharmaceuticals Limited 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 10 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 2 Aug 2021. 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 HaiMing Shi, doctor (+8613901824859, 13901824859@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference of HRR between the experimental group and the placebo group was significant (time frame: At the end of treatment (8 weeks (± 1 week))). 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 2 Aug 2021.