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

HUTCHMED

Status and phase: Completed; Phase 4

Conditions: Ischemia With Non-Obstructive Coronary Artery; X Syndrome, Angina; Coronary Heart Disease; Angina Pectoris

Treatments: Radiation: Placebo; Radiation: Shexiang Baoxin pill（MUSKARDIA）

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04897126

LESS202010

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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), 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

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

Treatment:

Radiation: Shexiang Baoxin pill（MUSKARDIA）

Placebo group

Placebo Comparator group

Description:

The control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.

Treatment:

Radiation: Placebo