Back to results

Effect of MUSK Pill on the Patients With Chest Pain Due to Non Obstructive Coronary Artery Disease (LESS)

Primary Purpose

Non Obstructive Coronary Artery Disease, Angina Pectoris, Coronary Heart Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

MUSK Pill

Placebo

About this trial

This is an interventional treatment trial for Non Obstructive Coronary Artery Disease focused on measuring Shexiang Baoxin Pill, Musk pill, patients with chest pain due to non obstructive coronary artery disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The age was 18-75 years old, and the gender was not limited;
The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), and coronary CTA or coronary angiography examination of coronary artery normal or lesions < 50%;
Willing to follow up and sign informed consent.

Exclusion Criteria:

Patients were selected and had no angina pectoris without medication
The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination;
Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism;
There were three months of acute myocardial infarction;
Severe respiratory disease, COPD or active pulmonary infection;
Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period;
Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr > 1.5 times of normal value), active liver disease, cirrhosis or uremia patients;
Any other serious diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness;
Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies;
Pregnant, lactating women and women and men with recent birth plans;
Allergic constitution or allergy to known components of the study drug;
The researchers judged that the patients who were not suitable for the study were not suitable.

Sites / Locations

Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

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

Changes of Seattle angina pectoris scale

Main evaluation indicators

Secondary Outcome Measures

Average number of angina attacks per week

Secondary evaluation index

Changes in total dosage of sublingual nitroglycerin buccal tablets

Secondary evaluation index

Changes of Seattle Angina scale item score

Secondary evaluation index

Changes of angina pectoris classification in CCS

Secondary evaluation index

Incidence of major cardiovascular events (MACE)

Secondary evaluation index

the incremental cost-effectiveness ratio (ICER) was used as the evaluation index

Pharmacoeconomic evaluation

Full Information

NCT ID

NCT04897126

First Posted

May 19, 2021

Last Updated

May 20, 2021

Sponsor

Shanghai Hutchison Pharmaceuticals Limited

Collaborators

Shanghai Changzheng Hospital, Shanghai University of Traditional Chinese Medicine, Jinshan Hospital Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04897126

Brief Title

Effect of MUSK Pill on the Patients With Chest Pain Due to Non Obstructive Coronary Artery Disease

Acronym

LESS

Official Title

Efficacy and Safety of MUSK Pill on the Patients With Chest Pain Due to Non Obstructive Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 11, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Hutchison Pharmaceuticals Limited

Collaborators

Shanghai Changzheng Hospital, Shanghai University of Traditional Chinese Medicine, Jinshan Hospital Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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 control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Obstructive Coronary Artery Disease, Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina

Keywords

Shexiang Baoxin Pill, Musk pill, patients with chest pain due to non obstructive coronary artery disease

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

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Active Comparator

Arm Description

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

Intervention Description

On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Changes of Seattle angina pectoris scale

Description

Main evaluation indicators

Time Frame

12 weeks ± 1 week

Secondary Outcome Measure Information:

Title

Average number of angina attacks per week

Description

Secondary evaluation index

Time Frame

12 weeks ± 1 week

Title

Changes in total dosage of sublingual nitroglycerin buccal tablets

Description

Secondary evaluation index

Time Frame

12 weeks ± 1 week

Title

Changes of Seattle Angina scale item score

Description

Secondary evaluation index

Time Frame

12 weeks ± 1 week

Title

Changes of angina pectoris classification in CCS

Description

Secondary evaluation index

Time Frame

12 weeks ± 1 week

Title

Incidence of major cardiovascular events (MACE)

Description

Secondary evaluation index

Time Frame

12 weeks ± 1 week

Title

the incremental cost-effectiveness ratio (ICER) was used as the evaluation index

Description

Pharmacoeconomic evaluation

Time Frame

12 weeks ± 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The age was 18-75 years old, and the gender was not limited; The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), and coronary CTA or coronary angiography examination of coronary artery normal or lesions < 50%; Willing to follow up and sign informed consent. Exclusion Criteria: Patients were selected and had no angina pectoris without medication The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination; Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism; There were three months of acute myocardial infarction; Severe respiratory disease, COPD or active pulmonary infection; Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period; Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr > 1.5 times of normal value), active liver disease, cirrhosis or uremia patients; Any other serious diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness; Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies; Pregnant, lactating women and women and men with recent birth plans; Allergic constitution or allergy to known components of the study drug; The researchers judged that the patients who were not suitable for the study were not suitable.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chun Liang

Phone

+8613801731588

chunliangliang@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Chen

Phone

+8615026930037

Chenhui_64@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun Liang

Organizational Affiliation

Shanghai Changzheng Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Changzheng Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chun Liang

Phone

+8613801731588

chunliangliang@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of MUSK Pill on the Patients With Chest Pain Due to Non Obstructive Coronary Artery Disease

We'll reach out to this number within 24 hrs