ST-Elevated Myocardial Infarction
Conditions
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. STEMI within 12 hours of onset (new ST-segment elevation of 2 or more adjacent leads >=1 mm (V2-V3 elevation >=2 mm); new-onset left bundle-branch block (LBBB); ST-segment elevation or Q wave in V1-V3 in right bundle-branch block (RBBB); 3. PPCI therapy is planned with first medical contact-balloon dilation is expected to be <=120min.
Exclusion criteria
Exclusion criteria: 1. Thrombolytic therapy patients; 2. Treated with heparin, low molecular weight heparin, fondaparinux, bivalirudin, or IIb/IIIa receptor antagonists within 48 hours prior to oral anticoagulants or first medical contact; 3. Cardiopulmonary resuscitation; 4. Cardiogenic shock; 5. Mechanical complications (heart wall rupture, ventricular septal perforation, papillary muscle dysfunction or rupture leading to severe mitral regurgitation); 6. Intracranial parenchymal aneurysm, intracranial arteriovenous malformation, history of intracranial hemorrhage, ischemic stroke or transient ischemic attack in the past 6 months, and history of active bleeding in the past 2 weeks; 7. Major surgery within one month; 8. Previous CABG; 9. History of heparin induced thrombocytopenia or known allergies to anticoagulant or antiplatelet drugs; 10. Other serious illnesses and an expected life expectancy of less than 12 months; 11. Pregnant or lactating women; 12. Participating in other clinical trail; 13. Refuse to sign the informed consent form; 14. The researcher determines that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days post-randomization.;BARC 3~5 within 30 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Net Clinical Adverse Events within 90 Days Post-Randomization (a composite of all-cause death, recurrent MI, urgent revascularization, stent thrombosis, stroke, HF rehospitalization, or BARC 3-5;Net Adverse Events within 30 Days Post-Randomization (a composite of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, stroke, or BARC 3~5);Proportion of Patients with Progression to SCAI Shock Stages C-E During Hospitalization;Individual Adverse Events within 30 Days Post-Randomization: all-cause death, cardiovascular death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, and stroke;Individual Adverse Events within 90 Days Post-Randomization: all-cause death, cardiovascular death, recurrent MI, urgent revascularization, stent thrombosis, stroke, HF rehospitalization, and BARC 3-5; | — |
Countries
China
Contacts
Public ContactJing Chen
Renmin Hospital of Wuhan University
Outcome results
None listed