Evaluate the Efficacy and Safety of MUSK Pill on Coronary Microvascular Dysfunction

Coronary Heart Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shexiang Baoxin Pill on Coronary Microvascular Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984954
• Other study ID #: HMPE202001
• Status: Recruiting
• Phase: Phase 4
• Start date: January 28, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2021
• Source: Shanghai Hutchison Pharmaceuticals Limited
• Contact: HaiMing Shi, doctor
• Phone: +8613901824859
• Email: 13901824859[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of life were also observed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-80, male or female;

2. Selective coronary angiography or coronary CTA showed that the diameter of coronary artery = 2.5mm, the degree of stenosis < 50%, without myocardial bridge;

3. They were able to perform treadmill exercise, and the treadmill test (EET) was positive;

4. Angina pectoris was found;

5. Patients are willing to follow up and sign informed consent; All the above criteria should be met.

Exclusion Criteria:

1. Coronary heart disease complicated with hypertrophic cardiomyopathy;

2. There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;

3. Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);

4. Mental disorders and mental diseases;

5. Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;

6. Contraindications of Shexiang Baoxin Pill: forbidden for pregnant women;

7. Those who have known history of allergy to Shexiang Baoxin Pills;

8. 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;

9. 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;

10. 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.

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Microvascular Angina
• Myocardial Ischemia

Intervention

Drug:
• MUSK pill
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

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hutchison Pharmaceuticals Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of treatment (8 weeks (± 1 week))