Clinical Trial

Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction

Study acronym: OPTIMA-6
Recruiting Phase 4
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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, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary percutaneous coronary intervention (PCI) improves outcomes in patients undergoing the procedure within 120 minutes. In this investigator-initiated, prospective, multi-center, randomized, double-blind, placebo-controlled trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trial group (r-SAK) or the control group (placebo). The risk of major adverse cardiovascular events within 90 days will be observed.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-06-06; most recent amendment 2024-10-24.
Status change: Not Yet Recruiting → Recruiting 2023-05-05
Trial Details
NCT Number NCT05410925
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions ST Elevation Myocardial Infarction
Enrollment 2,260 participants
Start Date 2023-04-08
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-28