Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

The First Affiliated Hospital of Dalian Medical University

Status and phase

Unknown

Phase 4

Conditions

Aging

Percutaneous Coronary Intervention

Acute Coronary Syndrome

Anticoagulants and Bleeding Disorders

Treatments

Drug: Heparin

Drug: Bivalirudin

Study type

Interventional

Funder types

Other

Identifiers

NCT04046029

PJ-KS-KY-2019-38(X)

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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