Status:
UNKNOWN
Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Collaborating Sponsors:
Beijing Friendship Hospital
Conditions:
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Eligibility:
All Genders
75+ years
Phase:
PHASE4
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 co...
Eligibility Criteria
Inclusion
- Age ≥75 years old;
- Planned elective PCI for patients with acute coronary syndrome;
- Life expectancy ≥ 1 year;
- Provide written informed consent.
Exclusion
- 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
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04046029
Start Date
July 8 2019
End Date
June 30 2021
Last Update
August 6 2019
Active Locations (1)
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1
The First Affiliated Hospital of Dalian Medical University
Dalian, China, 116011