Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Phase 4

• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention; Anticoagulants and Bleeding Disorders; Aging
• Interventions: Drug: Heparin; Drug: Bivalirudin

• Registration Number: NCT04046029
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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 coronary syndrome undergoing elective percutaneous coronary intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-08
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Study First Posted: 2019-08-06
• Last Update Posted: 2019-08-06
• Primary Completion: 2020-07-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin	Heparin	-
Bivalirudin	Bivalirudin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China