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

Coronary Heart Disease Clinical Trial

— LESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897126
• Other study ID #: LESS202010
• Status: Completed
• Phase: Phase 4
• Start date: May 11, 2021
• Est. completion date: October 25, 2023

Study information

• Verified date: April 2024
• Source: Shanghai Hutchison Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 25, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (12)

Lead Sponsor

Collaborator

Shanghai Hutchison Pharmaceuticals Limited

Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group, Shanghai Changzheng Hospital, Shanxi Cardiovascular Hospital, Tangshan Central Hospital, The First Hospital of Hebei Medical University, The Second Affiliated Hospital of Jiaxing University, The Second People's Hospital Of Bengbu, Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group, Zibo municipal hospital

Country where clinical trial is conducted

China, 

Outcome

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