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

Sponsor
Shenzhen People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05103813
Collaborator
(none)
100
1
1
14
7.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Beraprost Sodium Tablets
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Beraprost Sodium Tablets

Drug: Beraprost Sodium Tablets
Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction

Outcome Measures

Primary Outcome Measures

  1. Major Adverse Cardiovascular Events [1 weeks after baseline]

    The incidence of mace after 1 week of treatment

  2. Major Adverse Cardiovascular Events [6 months after baseline]

    The incidence of mace after 6 months of treatment

  3. Major Adverse Cardiovascular Events [1 year after baseline]

    The incidence of mace after 1 year of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenzhen People' S Hospital Shenzhen Guangdong China 518000

Sponsors and Collaborators

  • Shenzhen People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen People's Hospital
ClinicalTrials.gov Identifier:
NCT05103813
Other Study ID Numbers:
  • Beraprost Sodium treat STEMI
First Posted:
Nov 2, 2021
Last Update Posted:
Feb 8, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022