A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
The purpose of this research study is to obtain experience in the use of fondaparinux
(Arixtra) as compared to heparin when administered to patients who undergo percutaneous
coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a
coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and
heparin are drugs that inhibit blood clotting.
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
Children's Hospital Los Angeles
This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use
in adults (not in children) in a children aged 1-18 years. Subject with a blood clot
(thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be
eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by
blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper
dose for this age group. The hypothesis is that children receiving fondaparinux will be able
to receive a once daily dose. The currently available alternative agent, enoxaparin, needs
to be given twice daily. In addition, an evaluation of the safety of this medication will be
made by assessing for side effects, especially bleeding.
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