Bivalirudin as a Procedural Anticoagulant in Pediatrics

Cardiology Clinical Trial

Official title:

Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503126
• Other study ID #: TMC-BIV-07-01
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: November 8, 2011
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2011
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Pharmacokinetics and safety of weight based bivalirudin in children

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiology

Intervention

Drug:
• bivalirudin
anticoagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK/PD and safety		30 days	Yes