DRUG
Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
Status
Unknown
Phase
Phase 4
Enrollment
240
Locations
1
Results
Not posted
Publications
3
Study summary
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.
Interventions
DRUG
Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
DRUG
heparin with or without gpi during emergency PCI.
Timeline
First posted
Mar 20, 2019
Study start
Jan 16, 2019
Primary completion
Jul 14, 2020
Study completion
Dec 31, 2020
Results posted
Not reported
Registry updated
Mar 20, 2019
Outcomes
Major adverse cardiac events
Time frame · 7 days
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina,Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Major bleeding
Time frame · 7 days
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Major adverse cardiac events
Time frame · 30 days
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina,Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Stent thrombosis ,TVR ,TLR
Time frame · 30 days
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Major adverse cardiac events
Time frame · 180 days
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina,Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Stent thrombosis ,TVR ,TLR
Time frame · 180 days
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Eligibility
Inclusion Criteria: * Age ≥75 years old; * Planned emergency (Symptom onset within 24h) PCI for acute STEMI patients; * Life expectancy ≥ 1 year; * Provide written informed consent. Exclusion Criteria: * Contraindications to angiography or PCI; * Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc; * Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.); * Severe renal insufficiency (eGFR \< 30 mL/min/ 1.73 m2); * Elevated AST, ALT level higher than three times of the normal upper limit; * Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ) * Complicated with immune system diseases; * Abnormal hematopoietic system:platelet count \< 100 \* 109 / L or \> 700 \* 109 / L,white blood cell count \< 3 \* 109/L etc; * Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors; * Known intolerance, or contraindication to any antithrombotic medication * Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. * Non-cardiac co-morbid conditions are present that may result in protocol non-compliance; * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; * Patient's inability to fully cooperate with the study protocol
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Publications
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