Acute Coronary Syndrome, Aging, Anticoagulants and Bleeding Disorders, Percutaneous Coronary Intervention
Conditions
Keywords
Acute Coronary Syndrome, Percutaneous Coronary Intervention, Elderly, 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 coronary syndrome undergoing elective percutaneous coronary intervention.
Interventions
DRUGBivalirudin
Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.
DRUGHeparin
Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.
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 elective PCI for patients with acute coronary syndrome; * 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. |
| Major bleeding | 30 days | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. |
Countries
China
Contacts
Primary ContactShaoke Meng, M.D.
Backup ContactRongchong Huang, Ph.D.
Outcome results
None listed