Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedFebruary 8, 2022
October 1, 2021
8 months
October 21, 2021
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Major Adverse Cardiovascular Events
The incidence of mace after 1 week of treatment
1 weeks after baseline
Major Adverse Cardiovascular Events
The incidence of mace after 6 months of treatment
6 months after baseline
Major Adverse Cardiovascular Events
The incidence of mace after 1 year of treatment
1 year after baseline
Study Arms (1)
Beraprost Sodium Tablets
EXPERIMENTALInterventions
Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen People' S Hospital
Shenzhen, Guangdong, 518000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2021
First Posted
November 2, 2021
Study Start
May 1, 2022
Primary Completion
December 31, 2022
Study Completion
June 30, 2023
Last Updated
February 8, 2022
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share