FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes. A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH during PCI in High Risk Patients with UA/NSTEMI Initially Treated With Subcutaneous Fondaparinux
To compare the safety of two different dose regimens of unfractioned heparin (UFH) during a PCI procedure in patients with UA (unstable angina) /NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.
Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), parallel group design, safety study.
Adjudicated. Composite of major bleeding, minor bleeding or major vascular access site complications. Secondary Points: Composite of major bleeding with death, MI or target vessel revascularization. Major bleeding, minor bleeding assessed separately. Major vascular access site complications. Composite of death, MI, target vessel revascularization plus the components assessed separately. Stroke. Definite and probable stent thrombosis. Major PCI-related procedural complications. All primary and secondary endpoints are adjudicated.