Prolonged Clinical Follow-up of OPTIMA-5
ST-segment Elevation Myocardial Infarction (STEMI)
About this trial
This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring ST Elevation Myocardial Infarction, Recombinant Staphylokinase
Eligibility Criteria
Arm 1 and 2 inclusion and exclusion criteria Inclusion Criteria: Age 18-75 years, weight ≥45 kg; Diagnosed as STEMI (meeting the following two criteria simultaneously): i. Ischemic chest pain lasts ≥30 minutes; ii. Electrocardiogram indicates that ST-segment elevation ≥2 mm in 2 or more contiguous precordial leads or ≥1 mm in 2 or more peripheral leads; Time from onset of persistent chest pain to randomization <12 hours; Primary PCI expected to be performed within 120 minutes. Exclusion Criteria: Cardiogenic shock; Active bleeding or at high risk of bleeding (including grade Ⅲ or Ⅳ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within the past 1 month); Ischemic stroke or TIA in the past 6 months; History of hemorrhagic stroke; Platelet count <100×109/L or hemoglobin <100 g/L; Known intracranial aneurysm; Severe trauma, surgery or head injury within 1 month; Suspected aortic dissection or infective endocarditis; Recent puncture with difficult hemostasis by compression (eg, visceral biopsy, compartment puncture); Currently taking anticoagulants; Poorly controlled hypertension ( ≥180/110 mmHg); Hepatic or renal impairment (glutamic-pyruvic transaminase, glutamic oxalacetic transaminase, or γ -glutamyl transferase >2.5 times upper limit of normal value; creatinine >1.5 times upper limit of normal value); Known allergy to r-SAK; Pregnancy, lactation, or planning for pregnancy; History of myocardial infarction or CABG; Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset; Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators. Arm 3 inclusion and exclusion criteria Inclusion criteria Age ≥18, ≤75 years old, weight ≥45kg, gender is not limited; Taking maintenance dose of aspirin and ticagrelor for more than 3 days, or taking loading dose of aspirin (300mg) and ticagrelor (180mg); Inpatients with suspected coronary atherosclerotic heart disease scheduled for coronary angiography or interventional therapy. Exclusion criteria Patients who had received r-SAK thrombolytic therapy before; Previous diagnosis of Staphylococcus aureus infection; Patients who were participating in other clinical trials; Other patients considered unsuitable for inclusion by the investigators.
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical University
- Changzhou Second People's Hospital
- The second Affiliated Hospital of Dalian Medical University
- Huai 'an Second People's Hospital affiliated to Nanjing Medical University
- Lianyungang First People's Hospital
- Taizhou People's Hospital
- Affiliated Hospital of Jiangnan University
- The Second Affiliated Hospital of Zhejiang University Medical College
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
No Intervention
r-SAK group
normal saline group
patients with coronary artery disease
intravenous injection of single bolus 5 mg r-SAK in 3min
intravenous injection of 10ml saline in 3min, r-SAK and saline are the same in appearance
20 ml arterial blood samples were collected from patients before coronary angiography