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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 6 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. Known history of anemia with hemoglobin level \<10 g/dL
11. Known history of thrombocytopenia with platelet count \<100×10⁹/L
12. Poorly controlled hypertension ( ≥180/110 mmHg)
13. 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)
14. Known allergy to r-SAK
15. Pregnancy, lactation, or planning for pregnancy
16. History of chronic total occlusion, myocardial infarction or CABG
17. Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset
18. Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• Changzhou Second People's Hospital
  Changzhou, China Recruiting
• Changzhou Wujin People's Hospital
  Changzhou, China Recruiting
• The First People's Hospital of Changzhou
  Changzhou, China Recruiting
• Chongqing Hospital of Jiangsu Province Hospital
  Chongqing, China Recruiting
• The second Affiliated Hospital of Dalian Medical University
  Dalian, China Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Chunjian Li, PHD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Chunjian Li, PHD
• Email: lijay@njmu.edu.cn
• Phone: +86 13701465229

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.