Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Study Overview
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Brief Summary
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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.

Official Title
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Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome, Percutaneous Coronary Intervention, Aging, Anticoagulants and Bleeding Disorders

Intervention / Treatment
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* Drug: Bivalirudin
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bivalirudin<br> | Drug: Bivalirudin<br>* 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.<br>|
| Active Comparator: Heparin<br> | Drug: Heparin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation. | 7 days | 
| Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation. | 30 days | 
| Stent thrombosis ,TVR ,TLR | Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation. | 30 days | 
| Major adverse cardiac events | A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation. | 180 days | 
| Stent thrombosis ,TVR ,TLR | rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation | 180 days | 
| Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 30 days | 
| Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 180days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Percutaneous Coronary Intervention, Elderly, Bivalirudin