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Recruiting Phase 4

Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction

NCT05410925 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2023-04-08
Last updated
2026-10-30

Condition(s) studied

ST Elevation Myocardial Infarction

Investigational drug(s) / intervention(s)

Recombinant staphylokinasePlacebo

Recombinant staphylokinase: Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction

Placebo: Intravenous injection of placebo is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction

Study summary

As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early reperfusion may reduce the infarct size and improve the prognosis of patients. However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary percutaneous coronary intervention (PCI) improves outcomes in patients undergoing the procedure within 120 minutes.

In this investigator-initiated, prospective, multi-center, randomized, double-blind, placebo-controlled trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trial group (r-SAK) or the control group (placebo). The risk of major adverse cardiovascular events within 90 days will be observed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • MACE — Within 90 days
    Defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia

Trial sites (61)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu 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
Daqing Oilfield General Hospital Daqing China Recruiting
Dongguan People's Hospital Dongguan China Recruiting
Fengcheng People's Hospital Fengcheng China Recruiting
General Hospital of Southern Theatre Command Guangzhou China Recruiting
The Second Affiliated Hospital of Hainan Medical University Hainan China Recruiting
The Affiliated Hospital of Hangzhou Normal University Hangzhou China Recruiting
The Second Affiliated Hospital of Zhejiang University Medical College Hangzhou China Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Recruiting
Huai'an First People's Hospital Huai'an China Recruiting
Huai'an Second People's Hospital Huai'an China Recruiting
Donghai Country People's Hospital Lianyungang China Recruiting
The First People's Hospital of Lianyungang Lianyungang China Recruiting
The Second People's Hospital of Lianyungang Lianyungang China Recruiting
Liyang Hospital of Jiangsu Province Hospital Liyang China Recruiting
The First Affiliated Hospital of Nanchang University Nanchang China Recruiting
Nanjing Tongren Hospital Nanjing China Recruiting
Sir Run Run Hospital Nanjing Medical University Nanjing China Recruiting
The Fourth Affiliated Hospital of Nanjing Medical University Nanjing China Recruiting
Nanjing Qixia District Hospital Nanning China Recruiting
Affiliated Hospital of Nantong University Nantong China Recruiting
Nantong First People's Hospital Nantong China Recruiting
The People's Hospital of Zhalaite Neimeng China Recruiting
Qingdao Municipal Hospital Qingdao China Recruiting
Qilu Hospital of Shandong University Shandong China Recruiting
Renji Hospital affiliated to Shanghai Jiaotong University Shanghai China Recruiting
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
The People's Hospital of Liaoning Province Shenyang China Recruiting
Shenzhen People's Hospital Shenzhen China Recruiting
Suining County People's Hospital Suining China Recruiting
Nanjing Drum Tower Hospital Group Suqian Hospital Suqian China Recruiting
Suqian First Hospital Suqian China Recruiting
Suzhou Dushu Lake Hospital Suzhou China Recruiting
Suzhou Municipal Hospital of Anhui Province Suzhou China Recruiting
Suzhou Municipal Hospital Suzhou China Recruiting

+ 21 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05410925 on ClinicalTrials.gov ↗ ← All trials in China