Efficacy and Safety of an Early Phase Single-bolus r-SAK for Acute Myocardial Infarction - Trial NCT05410925
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.
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Study Focus
Sponsor & Location
The First Affiliated Hospital with Nanjing Medical University
Timeline & Enrollment
Phase 4
Jan 01, 2023
Jan 01, 2026
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
Data Source
ClinicalTrials.gov
NCT05410925
Non-Device Trial