Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

• Status: Unknown status
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University
• Collaborator: Beijing Friendship Hospital
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

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