Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI

Early Phase 1

• Conditions: Essential Hypertension
• Interventions: Drug: Beraprost Sodium Tablets

• Registration Number: NCT05103813
• Lead Sponsor: Shenzhen People's Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08
• Study Start: 2022-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Beraprost Sodium Tablets	Beraprost Sodium Tablets	-

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	1 year after baseline	The incidence of mace after 1 year of treatment

Trial Locations

Locations (1)

Shenzhen People' S Hospital; 🇨🇳 Shenzhen, Guangdong, China