Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Overview

Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2017

Detailed Description

Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Interventions

  • Drug: bivalirudin
    • Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
  • Drug: Heparin
    • Heparin is used in patients undergoing percutaneous coronary intervention.

Arms, Groups and Cohorts

  • Active Comparator: heparin
    • For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.
  • Experimental: not prolong infusion Bivalirudin
    • Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .
  • Experimental: prolong infusion bivalirudin
    • Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure.

Clinical Trial Outcome Measures

Primary Measures

  • creatine kinase-MB increase
    • Time Frame: up to postprocedural 72 hours
    • creatine kinase-MB increase >3 times upper limit of normal

Secondary Measures

  • bleeding(BARC class)
    • Time Frame: 30 days and 1 year
    • including BARC class 2-5
  • major adverse cardiac or cerebral events
    • Time Frame: 30 days and 1 year
    • a composite of all cause death, reinfarction, target vessel revascularization or stroke
  • Net Adverse Clinical Events
    • Time Frame: 30 days and 1 year
    • a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required. Exclusion Criteria:

  • cardiogenic shock; – thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; – active or recent major bleeding or bleeding predisposition; – major surgery within 1 month; – clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; – blood pressure higher than 180/110 mm Hg; – known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min; – history of heparin-induced thrombocytopenia; – allergy to any of the study drugs or devices; – pregnancy or lactation; – any condition making PCI unsuitable or that might interfere with study adherence; and – patient unwilling or unable to provide written informed consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yun Dai Chen, Chinese PLA General Hospital – Chinese PLA General Hospital
  • Overall Contact(s)
    • Yundai chen, doctor, +08613581886786, dingyutinkle@163.com

References

Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323.

Citations Reporting on Results

Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.

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