Aging Clinical Trial
Official title:
Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | June 30, 2021 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility |
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 =?) 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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Dalian Medical University | Dalian |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Dalian Medical University | Beijing Friendship Hospital |
China,
De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28. Review. — View Citation
Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. — View Citation
Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 7 days | |
Secondary | 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 | |
Secondary | Stent thrombosis ,TVR ,TLR | Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation. | 30 days | |
Secondary | 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 | |
Secondary | Stent thrombosis ,TVR ,TLR | rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation | 180 days | |
Secondary | Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 30 days | |
Secondary | Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 180days |
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