Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Beraprost Sodium Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility Criteria
Inclusion Criteria:
- It meets the diagnostic criteria of acute ST segment elevation myocardial infarction: ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; ST segment elevation of ECG with two or more adjacent leads, limb lead ≥ 1mm, chest lead ≥ 2mm; Or new left bundle branch block; The serum markers of myocardial necrosis increased at least twice the normal value
- Acute myocardial infarction was confirmed by coronary angiography
- The clinical and angiographic data were complete
- Direct PCI was performed within 12 hours after onset
Exclusion Criteria:
- Those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test
- Conscious disorder, obvious intellectual disorder and mental disorder
- With metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc
- People with claustrophobia
- Had a history of myocardial infarction, PCI and coronary artery bypass grafting
- Factors affecting ST segment changes of ECG: complete left bundle branch block, preexcitation syndrome, pacemaker ECG, etc
Sites / Locations
- Shenzhen People' S HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Beraprost Sodium Tablets
Arm Description
Outcomes
Primary Outcome Measures
Major Adverse Cardiovascular Events
The incidence of mace after 1 week of treatment
Major Adverse Cardiovascular Events
The incidence of mace after 6 months of treatment
Major Adverse Cardiovascular Events
The incidence of mace after 1 year of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05103813
First Posted
October 21, 2021
Last Updated
February 7, 2022
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05103813
Brief Title
Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI
Official Title
Protective Effect of Beraprost Sodium Tablets on Coronary Microcirculation Function and Ventricular Remodeling After Reperfusion Therapy for Acute ST Segment Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beraprost Sodium Tablets
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Beraprost Sodium Tablets
Intervention Description
Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
The incidence of mace after 1 week of treatment
Time Frame
1 weeks after baseline
Title
Major Adverse Cardiovascular Events
Description
The incidence of mace after 6 months of treatment
Time Frame
6 months after baseline
Title
Major Adverse Cardiovascular Events
Description
The incidence of mace after 1 year of treatment
Time Frame
1 year after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
It meets the diagnostic criteria of acute ST segment elevation myocardial infarction: ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; ST segment elevation of ECG with two or more adjacent leads, limb lead ≥ 1mm, chest lead ≥ 2mm; Or new left bundle branch block; The serum markers of myocardial necrosis increased at least twice the normal value
Acute myocardial infarction was confirmed by coronary angiography
The clinical and angiographic data were complete
Direct PCI was performed within 12 hours after onset
Exclusion Criteria:
Those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test
Conscious disorder, obvious intellectual disorder and mental disorder
With metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc
People with claustrophobia
Had a history of myocardial infarction, PCI and coronary artery bypass grafting
Factors affecting ST segment changes of ECG: complete left bundle branch block, preexcitation syndrome, pacemaker ECG, etc
Facility Information:
Facility Name
Shenzhen People' S Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Bo He
Phone
13434792084
Email
527768709@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI
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