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The OPTIMA-5 Trail

NCT05023681 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-01-13

No results posted yet for this study

Summary

This study was a prospective, multicenter, randomized, controlled, excellence clinical trial. Subjects meeting the inclusion/exclusion criteria were randomly assigned 1:1 to r-SAK group or the control group (normal saline). Emergency coronary angiography was performed and cardiac magnetic resonance imaging was performed 5 days after surgery, followed up to 30 days.

At present, there is still a lack of clinical evidence on whether thrombolytic therapy is performed for acute ST-segment elevation myocardial infarction \<2 hours after the first medical contact and prime PCI. Compared to prime PCI, early thrombolytic therapy can undoubtedly shorten the implementation time of reperfusion strategy to the maximum. For highly effective thrombolytic drugs, it should also shorten the reperfusion time, reduce thrombotic load, possibly reduce the area of myocardial infarction and improve the prognosis of patients. In this study, normal saline was used as the control. To observe the efficacy of thrombolytic therapy with single intravenous infusion of recombinant glucokinase (r-SAK) at the first time in acute ST-segment elevation myocardial infarction. And the effect of r-SAK on improving myocardial tissue level perfusion, reducing myocardial infarction size, improving cardiac function and clinical prognosis in STEMI patients.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Recombinant Staphylokinase

Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction

DRUG

normal saline

Intravenous injection of placebo(normal saline ) is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2022-08-14
Completion
2022-09-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023681 on ClinicalTrials.gov