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CompletedNCT00043277Updated Feb 1, 2006

Study Of Angiomax In Infants Under Six Months With Thrombosis

A Phase 2 interventional study of Angiomax (bivalirudin) in Thrombosis, sponsored by The Medicines Company. Completed at 1 site in United States. Open to participants aged 0 Years to 6 Months. Per ClinicalTrials.gov, last updated 2006-02-01.

Sponsored by The Medicines Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
0 Years to 6 Months
Sex
All
01

Study summary

The goals of this study are:

  1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
  2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
  3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
Read the detailed description

The goals of this study are:

  1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
  2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
  3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
02

Conditions studied

  • Thrombosis

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Keywords

  • neonates
  • thrombosis
  • bivalirudin
  • direct thrombin inhibitor
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 25 is below the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

The Medicines Company is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
  • Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
  • Age less than 6 months .
  • Gestational age greater than 35 weeks
  • Expected life expectancy at least 14 days.
  • No contraindication to anticoagulation i.e. bleeding complications.

Exclusion criteria

Exclusion Criteria:

  • Active or recent (less than 7 days) bleeding.
  • Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
  • Refusal to undergo blood transfusion should it become necessary.
  • Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
  • Baseline prolonged PT (>18 secs) or aPTT (>55 secs)
  • Platelet count \< 50,000 cells/mm3
  • Birth Trauma
  • Planned or indicated surgery within 30 days
  • Major or minor bleeding event
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants

Interventions

  • DrugAngiomax (bivalirudin)
06

What researchers measure

Primary outcomes

  1. Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.

Secondary outcomes

  1. In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

07

Study locations

1 site
  • Children's Hospital of Orange County
    Orange, California 92868, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00043277
Lead sponsor
The Medicines Company
First posted
Aug 8, 2002
Start date
Aug 2002
Completion
Dec 2004
Last update
Feb 1, 2006

Study contacts

Guy Young, MD
principal investigator · Children's Hospital Orange County
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

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