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RECRUITINGPhase 4INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Recombinant staphylokinase

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

DRUG

Placebo

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

Locations (20)

The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Changzhou Second People's Hospital
Changzhou, China
Changzhou Wujin People's Hospital
Changzhou, China
The First People's Hospital of Changzhou
Changzhou, China
Chongqing Hospital of Jiangsu Province Hospital
Chongqing, China
The second Affiliated Hospital of Dalian Medical University
Dalian, China
Daqing Oilfield General Hospital
Daqing, China
Dongguan People's Hospital
Dongguan, China
Fengcheng People's Hospital
Fengcheng, China
General Hospital of Southern Theatre Command
Guangzhou, China
The Second Affiliated Hospital of Hainan Medical University
Hainan, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huai'an First People's Hospital
Huai'an, China
Huai'an Second People's Hospital
Huai'an, China
Donghai Country People's Hospital
Lianyungang, China
The First People's Hospital of Lianyungang
Lianyungang, China
The Second People's Hospital of Lianyungang
Lianyungang, China
Liyang Hospital of Jiangsu Province Hospital
Liyang, China