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Using half-dose recombinant staphylokinase before heart procedure for heart attack patients

Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction: a Multicenter Randomized Double-blind Placebo-controlled Trial (OPTIMA-6)

Phase 4 Interventional The First Affiliated Hospital with Nanjing Medical University · NCT05410925

This study is testing if giving a half-dose of a new heart medication before a heart procedure can help heart attack patients feel better and avoid serious complications.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment2260 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorThe First Affiliated Hospital with Nanjing Medical University Academic / other
Locations61 sites (Nanjing, Jiangsu and 60 other locations)
Trial IDNCT05410925 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of administering a half-dose bolus of recombinant staphylokinase (r-SAK) prior to primary percutaneous coronary intervention (PCI) in patients diagnosed with ST-elevation myocardial infarction (STEMI). It is a prospective, multi-center, randomized, double-blind, placebo-controlled trial where participants will be randomly assigned to receive either r-SAK or a placebo. The study aims to determine if this adjunctive thrombolytic therapy can improve outcomes and reduce the risk of major adverse cardiovascular events within 90 days of treatment. The trial focuses on patients who are expected to undergo PCI within a specific time frame after the onset of chest pain.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 years who have been diagnosed with STEMI and are expected to undergo primary PCI within 120 minutes of symptom onset.

Not a fit: Patients with conditions such as cardiogenic shock, active bleeding, or a history of severe strokes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the treatment outcomes for patients experiencing STEMI by reducing infarct size and improving prognosis.

How similar studies have performed: While the specific use of r-SAK in this context may be novel, previous studies have shown that thrombolytic therapy can be beneficial in managing STEMI.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 18-75 years, weight ≥45 kg
2. Diagnosed as STEMI (meeting the following two conditions simultaneously)

   1. Ischemic chest pain lasts ≥ 30 minutes
   2. ECG indicates that ST-segment elevation of two or more contiguous precordial leads ≥ 0.1 mV, or ST-segment elevation of two or more contiguous precordial leads ≥ 0.2 mV
3. Time from onset of persistent chest pain to randomization ≤12 hours
4. Primary PCI expected to be performed ≥30 minutes, and ≤120 minutes

Exclusion Criteria:

1. Cardiogenic shock
2. Active bleeding or known 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. Known intracranial aneurysm
6. Severe trauma, surgery or head injury within 1 month
7. Suspected aortic dissection or infective endocarditis
8. Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
9. Currently taking anticoagulants
10. Poorly controlled hypertension ( ≥180/110 mmHg)
11. Severe hepatic or renal impairment indicated by the consultation or previous history (glutamic-pyruvic transaminase or glutamic oxalacetic transaminase \>3 times upper limit of normal value; eGFR \<15 ml/min/1.73m\^2, calculated based on CKD-EPI)
12. Known allergy to r-SAK
13. Pregnancy, lactation, or planning for pregnancy
14. History of chronic total occlusion, myocardial infarction or CABG
15. Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset
16. Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators

Where this trial is running

Nanjing, Jiangsu and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ST Elevation Myocardial InfarctionRecombinant StaphylokinaseThrombolysis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.