Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery (LESS)

Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Angina Pectoris; Coronary Heart Disease; X Syndrome, Angina; Ischemia With Non-Obstructive Coronary Artery
• Intervention / Treatment: Radiation: Shexiang Baoxin pill（MUSKARDIA）; Radiation: Placebo

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Shanghai Changzheng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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), Within 1 year, 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
• History of vascular reconstruction within 6 months, CABG or PCI;
• Preparation for CABG or PCI during the trial period
• 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.

(Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group; The experimental group was treated with Shexiang Baoxin pill（MUSKARDIA） (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up	Radiation: Shexiang Baoxin pill（MUSKARDIA）; On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.; Other Names: routine treatment
Placebo Comparator: Placebo group; The control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.	Radiation: Placebo; On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.; Other Names: routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Seattle angina pectoris scale	Main evaluation indicators	12 weeks ± 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of angina attacks per week	Secondary evaluation index	12 weeks ± 1 week
Changes in total dosage of sublingual nitroglycerin buccal tablets	Secondary evaluation index	12 weeks ± 1 week
Changes of angina pectoris classification in CCS	Secondary evaluation index	12 weeks ± 1 week
Incidence of major cardiovascular events (MACE)	Secondary evaluation index	12 weeks ± 1 week
the incremental cost-effectiveness ratio (ICER) was used as the evaluation index	Pharmacoeconomic evaluation	12 weeks ± 1 week

Collaborators and Investigators

• Sponsor: Shanghai Hutchison Pharmaceuticals Limited
• Collaborators: Shanghai Changzheng Hospital; The First Hospital of Hebei Medical University; Shanxi Cardiovascular Hospital; The Second Affiliated Hospital of Jiaxing University; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Zibo Municipal Hospital; Tangshan Central Hospital; The Second People's Hospital Of Bengbu; Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group; Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group; General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
• Investigators: Principal Investigator: Chun Liang, Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): July 4, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Shexiang Baoxin Pill; patients with chest pain due to non obstructive coronary artery disease; MUSKARDIA
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Angina Pectoris; Microvascular Angina
• Other Study ID Numbers: LESS202010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No