ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
ST Elevation Myocardial Infarction, Recombinant Staphylokinase
Brief summary
The OPTIMA-5 trial is a prospective, multi-center, randomized, patient blinded, controlled trial comparing a single bolus of half-dose recombinant staphylokinase (r-SAK) with normal saline (NS) in patients with ST-segment elevation myocardial infarction (STEMI) presenting ≤12 hours of symptom onset and expected to undergo primary percutaneous coronary intervention (PPCI) within 120 minutes. The results of OPTIMA-5 showed that a single bolus r-SAK prior to PPCI for STEMI improves infarct related artery (IRA) patency and reduces infarct size without increasing major bleeding. On this basis, this study was designed to investigate the effect of the novel reperfusion strategy on 1-year outcomes of patients with STEMI.
Detailed description
Acute myocardial infarction (AMI) is one of the leading causes of death all over the world, and accounted for more than 100 thousand deaths in the US in 2019. Early PPCI reduces mortality in patients with STEMI. If PPCI cannot be performed within 120 minutes of presentation, guidelines recommend the use of thrombolytic therapy. However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to PPCI improves outcomes in patients undergoing the procedure within 120 minutes. SAK is a fibrin specific fibrinolytic agent produced by Staphylococcus aureus that was first discovered in 1948. A recombinant form of SAK was approved by China Food and Drug Administration (CFDA) for treatment of patients with STEMI. It has been demonstrated that r-SAK is more potent than urokinase and recombinant streptokinase in rabbit models. The OPTIMA-5 trial is an investigator-initiated, prospective, multi-center, randomized, patient blinded, controlled trial comparing a single bolus of half-dose r-SAK with NS in patients with STEMI presenting ≤12 hours of symptom onset and expected to undergo PPCI within 120 minutes. Between October 29, 2021 and August 14, 2022, 283 STEMI patients were screened in 8 centers in China and 200 were randomized to r-SAK group or control in a 1:1 ratio using a computer-generated randomization sequence. On this basis, this study was aimed to conduct a 1-year follow-up study to further confirm the efficacy and safety of this novel reperfusion strategy for patients with STEMI.
Interventions
Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
DRUGNormal Saline
Intravenous injection of normal saline is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Arm 1 and 2 inclusion and
Exclusion criteria
Inclusion Criteria: 1. Age 18-75 years, weight ≥45 kg; 2. Diagnosed as STEMI (meeting the following two criteria simultaneously): i. Ischemic chest pain lasts ≥30 minutes; ii. Electrocardiogram indicates that ST-segment elevation ≥2 mm in 2 or more contiguous precordial leads or ≥1 mm in 2 or more peripheral leads; 3. Time from onset of persistent chest pain to randomization \<12 hours; 4. Primary PCI expected to be performed within 120 minutes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | Within 360 days | A composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse cardiac and cerebrovascular events | Within 360 days | Each of the above independent MACE events, cardiovascular death, cardiac mechanical complications and stroke. |
Other
| Measure | Time frame | Description |
|---|---|---|
| r-SAK antibody level in human serum | Day 90 ± 7, Day 180 ± 7, Day 360 ± 14 | Recombinant staphylokinase (r-SAK) antibody level in human serum |
| In-vitro thrombolysis rate | 60 minutes after In-vitro thrombolysis | In-vitro thrombolysis rate |
| r-SAK activity before and after in-vitro thrombolysis | Immediately before in-vitro thrombolysis and 60 minutes after In-vitro thrombolysis | r-SAK activity before and after in-vitro thrombolysis |
Countries
China
Outcome results
None listed