Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat
patients with obstructive coronary artery disease (CAD). Although PCI is highly effective for
the management of CAD, it can potentiate an existing prothrombotic state around lesion areas.
A certain level of anticoagulation is required to perform planned PCI safely and to minimize
the periprocedural risk of thrombosis and its attendant complications, including myocardial
ischemia and infarction (heart attack). Many different anti-thrombotic regimens have been
investigated and are currently in use. The aim of this study is to explore whether
Rivaroxaban, as compared to unfractionated heparin, on the background of standard dual
antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic
events, upon balloon inflation and stent expansion, during elective PCI, without increasing
bleeding. The treatment assignment will be done in a semi-blinded design, eg, no blinding for
randomization either to Rivaroxaban (one of the three arms) or the control (UFH) group.
However, all will be blinded for the treatment dose of rivaroxaban (either 10mg or 20 mg).The
10 mg rivaroxaban plus 50 IU UFH arm will not be blinded.