1-Year Follow-up of OPTIMA-5

• Status: Active, not recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

1. Age ≥ 18, ≦75 years old, weight ≥45kg, gender is not limited.

2. Diagnosis of acute ST-segment elevation myocardial infarction (both of the following) (A) Ischemic chest pain lasting more than 30 minutes; (B) Ecg indicates ST-segment elevation ≥ 0.1mV in 2 or more limb leads, or ST-segment elevation ≥ 0.2mV in 2 or more adjacent chest leads;

3. Time from onset of persistent ischemic chest pain to randomization ≤12 hours;

4. Coronary angiography and/or PCI are expected to be performed within 2 hours of r-SAK thrombolysis.

Exclusion Criteria:

1. Non-ST-segment elevation myocardial infarction;

2. STEMI with cardiogenic shock;

3. Active bleeding or bleeding tendency, including Ⅲ, Ⅳ period history of retinopathy, retinal hemorrhage, gastrointestinal tract and urinary tract hemorrhage (1 month), ischemic stroke happened over the past 6 months, transient ischemic attack (TIA) happened over the past 6 weeks, hemorrhagic stroke in the past, unexplained platelet count < 100 x 109 / L or Hemoglobin <100g/L;

4. Having a history of central nervous system trauma or known intracranial aneurysm;

5. Recent (within 1 month) severe trauma, surgery or head injury;

6. Suspected aortic dissection, infective endocarditis;

7. Recent history of puncture which difficult hemostasis by compression (visceral biopsy, compartment puncture);

8. Long-term use and/or current use of anticoagulant drugs;

9. Hypertension not well controlled ≥180/110mmHg;

10. Having severe hepatic and renal impairment (ALT, AST, γ-GT > 2.5 times the upper limit of normal value; Cr > 1.5 times upper normal);

11. Known allergies to r-SAK;

12. Pregnant, breastfeeding or planned pregnancy women and male patients with family planning;

13. Patients who have participated in other clinical trials in the past 3 months;

14. Having a history of myocardial infarction or CABG;

15. Having taken antiplatelet drugs after pain onset, such as clopidogrel, prasugrel, cilostazol etc;

16. Other reasons that patients considered unsuitable for inclusion by researchers.