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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
Shenzhen People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 21, 2021
Last Updated
February 7, 2022
Sponsor
Shenzhen People's Hospital
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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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