Clinical trial NCT04897126: Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemia With Non-Obstructive Coronary Artery
Angina Pectoris
Coronary Heart Disease
X Syndrome, Angina
Keywords: Shexiang Baoxin Pill
MUSKARDIA
patients with chest pain due to non obstructive coronary artery disease
Lead sponsor: Shanghai Hutchison Pharmaceuticals Limited
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Changzheng Hospital
name: The Second People's Hospital Of Bengbu
name: The Second Affiliated Hospital of Jiaxing University
name: Zibo Central Hospital
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Shanxi Cardiovascular Hospital
name: The First Hospital of Hebei Medical University
name: Tangshan Central Hospital
name: Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group
name: Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group
name: General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
First posted: 2021-05-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 stratified block random grouping according to the center
Primary purpose: TREATMENT

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.


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), 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.)

Primary outcomes:
measure: Changes of Seattle angina pectoris scale
timeFrame: 12 weeks ± 1 week
Secondary outcomes:
measure: Average number of angina attacks per week
timeFrame: 12 weeks ± 1 week
measure: Changes in total dosage of sublingual nitroglycerin buccal tablets
timeFrame: 12 weeks ± 1 week
measure: Changes of angina pectoris classification in CCS
timeFrame: 12 weeks ± 1 week
measure: Incidence of major cardiovascular events (MACE)
timeFrame: 12 weeks ± 1 week
measure: the incremental cost-effectiveness ratio (ICER) was used as the evaluation index
timeFrame: 12 weeks ± 1 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Chun Liang
role: PRINCIPAL_INVESTIGATOR
References: