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

Primary Purpose

Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
MUSK pill
Sponsored by
Shanghai Hutchison Pharmaceuticals Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Shexiang Baoxin Pill, Musk pill, Patients with coronary microvascular dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Huashan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

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

The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2021
Last Updated
July 20, 2021
Sponsor
Shanghai Hutchison Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04984954
Brief Title
Evaluate the Efficacy and Safety of MUSK Pill on Coronary Microvascular Dysfunction
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shexiang Baoxin Pill on Coronary Microvascular Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hutchison Pharmaceuticals Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina, Non Obstructive Coronary Artery Disease
Keywords
Shexiang Baoxin Pill, Musk pill, Patients with coronary microvascular dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
1:1 stratified block random grouping according to the center
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up.
Intervention Type
Drug
Intervention Name(s)
MUSK pill
Other Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
the difference of HRR between the experimental group and the placebo group was significant
Description
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.
Time Frame
At the end of treatment (8 weeks (± 1 week))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HaiMing Shi, doctor
Phone
+8613901824859
Email
13901824859@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Shan, doctor
Phone
+8613402021699
Email
shanyingli@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HaiMing Shi, doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital Fudan University
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiming Shi, doctor
Phone
+8613801731588
Email
13901824859@163.com
First Name & Middle Initial & Last Name & Degree
Ying Shan, doctor
Phone
+8613402021699
Email
shanyingli@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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