Status:
RECRUITING
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 uncerta...
Detailed Description
Acute myocardial infarction (AMI) is a serious and critical disease that causes acute coronary artery stenosis, spasm or occlusion due to the rupture or erosion of coronary artery plaque, resulting in...
Eligibility Criteria
Inclusion
- Age 18-75 years, weight ≥45 kg
- Diagnosed as STEMI (meeting the following two conditions simultaneously)
- Ischemic chest pain lasts ≥ 30 minutes
- 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
- Time from onset of persistent chest pain to randomization ≤12 hours
- Primary PCI expected to be performed ≥30 minutes, and ≤120 minutes
Exclusion
- Cardiogenic shock
- 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)
- Ischemic stroke or TIA in the past 6 months
- History of hemorrhagic stroke
- Known intracranial aneurysm
- Severe trauma, surgery or head injury within 1 month
- Suspected aortic dissection or infective endocarditis
- Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
- Currently taking anticoagulants
- Poorly controlled hypertension ( ≥180/110 mmHg)
- 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)
- Known allergy to r-SAK
- Pregnancy, lactation, or planning for pregnancy
- History of chronic total occlusion, 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
Key Trial Info
Start Date :
April 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
2260 Patients enrolled
Trial Details
Trial ID
NCT05410925
Start Date
April 8 2023
End Date
December 31 2027
Last Update
October 28 2024
Active Locations (61)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
2
Changzhou Second People's Hospital
Changzhou, China
3
Changzhou Wujin People's Hospital
Changzhou, China
4
The First People's Hospital of Changzhou
Changzhou, China