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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hutchison Pharmaceuticals Limited
• Collaborators: Jinshan Hospital Fudan University; Shanghai Changzheng Hospital; Shanghai University of Traditional Chinese Medicine

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.