Bivalirudin as a Procedural Anticoagulant in Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503126
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : November 10, 2011
Information provided by (Responsible Party):
The Medicines Company

Brief Summary:
Pharmacokinetics and safety of weight based bivalirudin in children

Condition or disease Intervention/treatment Phase
Cardiology Drug: bivalirudin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease
Study Start Date : August 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bivalirudin
U.S. FDA Resources

Intervention Details:
    Drug: bivalirudin
    Other Name: Angiomax/Angiox

Primary Outcome Measures :
  1. PK/PD and safety [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and non-pregnant females, with an age range of birth to 16 years of age.
  • Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
  • Written informed consent from a legal guardian/parent.
  • Life expectancy of at least 15 days at study entry.
  • Assent of the patient if older than 8 years, whenever possible.

Exclusion Criteria:

  • History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
  • Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
  • Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
  • Known congenital or acquired bleeding or clotting disorder.
  • Patients undergoing renal dialysis.*
  • Weight < 2.5 kg.
  • Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
  • Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).
  • Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
  • Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.
  • Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is > 1.5.
  • Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.
  • Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.
  • Patients previously enrolled in the study.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: The Medicines Company Identifier: NCT00503126     History of Changes
Other Study ID Numbers: TMC-BIV-07-01
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by The Medicines Company:

Additional relevant MeSH terms:
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents