Aged, Percutaneous Coronary Intervention, STEMI
Conditions
Keywords
Major adverse cardiac events (MACEs), bivalirudin
Brief 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
DRUGBivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
DRUGHeparin
heparin with or without gpi during emergency PCI.
Sponsors
Beijing Friendship Hospital
The First Affiliated Hospital of Dalian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 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 | 7 days | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 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 | 30 days | rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation |
Countries
China
Contacts
Primary ContactRongchong Huang, M.D.
Outcome results
None listed