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

Phase 4

• Conditions: Non Obstructive Coronary Artery Disease; Angina Pectoris; X Syndrome, Angina; Coronary Heart Disease
• Interventions: Drug: MUSK pill

• Registration Number: NCT04984954
• Lead Sponsor: Shanghai Hutchison Pharmaceuticals Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	MUSK pill	The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up.
Experimental group	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

Primary Outcome Measures

Name	Time	Method
the difference of HRR between the experimental group and the placebo group was significant	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.

Trial Locations

Locations (1)

Huashan Hospital Fudan University; 🇨🇳 ShangHai, Shanghai, China