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NCT05410925Not yet recruiting

Efficacy and Safety of an Early Phase Single-bolus r-SAK for Acute Myocardial Infarction

Efficacy and Safety of an Early Phase Single-bolus r-SAK for Acute Myocardial Infarction: a Multi-center Randomized Clinical Trial (OPTIMA-6)
The First Affiliated Hospital with Nanjing Medical UniversityPhase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Acute Myocardial Infarction
Drug/Device/Intervention
Recombinant staphylokinase
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
The First Affiliated Hospital with Nanjing Medical University
Location
Nanjing, China
Timeline & enrollment
Phase
Phase 4
Start date
Jan 01, 2023
End date
Jan 01, 2026
Enrollment
2000 participants
Primary outcome

Efficacy end point: major adverse cardiovascular events,Safety end point: bleeding events

Summary

As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early
 reperfusion may reduce the infarct size and improve the prognosis of patients. However, for
 patients whose first medical contact to emergency percutaneous coronary intervention (PCI)
 takes less than 2 hours, there is still lack of research evidence on whether thrombolytic
 therapy before PCI can increase the benefits of patients.
 
 In this prospective, multicenter, randomized, controlled, excellence clinical trial, subjects
 meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trail group
 (r-SAK) or the control group (normal saline). The risk of major adverse cardiovascular events
 within 1 year and bleeding events within 30 days were observed.

ICD-10 classifications
Acute myocardial infarctionAcute myocardial infarction, unspecifiedAcute subendocardial myocardial infarctionCertain current complications following acute myocardial infarctionOther current complications following acute myocardial infarction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05410925
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05410925 through Pure Global AI's free database. This Phase 4 trial is sponsored by The First Affiliated Hospital with Nanjing Medical University and is currently Not yet recruiting. The study focuses on Acute Myocardial Infarction. Target enrollment is 2000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.