Prolonged Clinical Follow-up of OPTIMA-5

February 22, 2024 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

A Single Bolus r-SAK Prior to Primary PCI for ST-elevation Myocardial Infarction (OPTIMA-5): 1-Year Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Changzhou, China
        • Changzhou Second People's Hospital
      • Dalian, China
        • The Second Affiliated Hospital of Dalian Medical University
      • Huai'an, China
        • Huai 'an Second People's Hospital affiliated to Nanjing Medical University
      • Lianyungang, China
        • Lianyungang First People's Hospital
      • Taizhou, China
        • Taizhou People's Hospital
      • Wuxi, China
        • Affiliated Hospital Of Jiangnan University
      • Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University Medical College
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

  1. Cardiogenic shock;
  2. Active bleeding or at high risk of bleeding (including grade Ⅲ or Ⅳ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within the past 1 month);
  3. Ischemic stroke or TIA in the past 6 months;
  4. History of hemorrhagic stroke;
  5. Platelet count <100×109/L or hemoglobin <100 g/L;
  6. Known intracranial aneurysm;
  7. Severe trauma, surgery or head injury within 1 month;
  8. Suspected aortic dissection or infective endocarditis;
  9. Recent puncture with difficult hemostasis by compression (eg, visceral biopsy, compartment puncture);
  10. Currently taking anticoagulants;
  11. Poorly controlled hypertension ( ≥180/110 mmHg);
  12. Hepatic or renal impairment (glutamic-pyruvic transaminase, glutamic oxalacetic transaminase, or γ -glutamyl transferase >2.5 times upper limit of normal value; creatinine >1.5 times upper limit of normal value);
  13. Known allergy to r-SAK;
  14. Pregnancy, lactation, or planning for pregnancy;
  15. History of myocardial infarction or CABG;
  16. Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset;
  17. Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators.

Arm 3 inclusion and exclusion criteria Inclusion criteria

  1. Age ≥18, ≤75 years old, weight ≥45kg, gender is not limited；
  2. Taking maintenance dose of aspirin and ticagrelor for more than 3 days, or taking loading dose of aspirin (300mg) and ticagrelor (180mg);
  3. Inpatients with suspected coronary atherosclerotic heart disease scheduled for coronary angiography or interventional therapy.

Exclusion criteria

  1. Patients who had received r-SAK thrombolytic therapy before;
  2. Previous diagnosis of Staphylococcus aureus infection;
  3. Patients who were participating in other clinical trials;
  4. Other patients considered unsuitable for inclusion by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: r-SAK group
intravenous injection of single bolus 5 mg r-SAK in 3min
Drug: Recombinant Staphylokinase
Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Placebo Comparator: normal saline group
intravenous injection of 10ml saline in 3min, r-SAK and saline are the same in appearance
Drug: Normal Saline
Intravenous injection of normal saline is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
No Intervention: patients with coronary artery disease
20 ml arterial blood samples and 5 ml venous blood samples were collected from patients before coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: Within 360 days
A composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia
Within 360 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse cardiac and cerebrovascular events
Time Frame: Within 360 days
Each of the above independent MACE events, cardiovascular death, cardiac mechanical complications and stroke.
Within 360 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
r-SAK antibody level in human serum
Time Frame: Day 90 ± 7, Day 180 ± 7, Day 360 ± 14
Recombinant staphylokinase (r-SAK) antibody level in human serum
Day 90 ± 7, Day 180 ± 7, Day 360 ± 14
In-vitro thrombolysis rate
Time Frame: 60 minutes after In-vitro thrombolysis
In-vitro thrombolysis rate
60 minutes after In-vitro thrombolysis
r-SAK activity before and after in-vitro thrombolysis
Time Frame: Immediately before in-vitro thrombolysis and 60 minutes after In-vitro thrombolysis
r-SAK activity before and after in-vitro thrombolysis
Immediately before in-vitro thrombolysis and 60 minutes after In-vitro thrombolysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Actual)

September 14, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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