This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Currently available anticoagulants include un-fractionated heparin (UFH), low-molecular weight heparins (LMWH), and direct thrombin inhibitors (DTI). Generally, cardiovascular clinicians have been willing to trade off an increased risk of bleeding from these drugs when the drug can reduce theischemic complications of either the acute coronary syndromes or of coronary revascularization procedures. However, recent data have suggested that bleeding events, particularly those that require blood transfusion, have a significant impact on the outcome and cost of treatment of patients withACS. Therefore, despite the continued development of novel antithrombotics, a significant clinical need exists for safer anticoagulant agents. The REG 1 Anticoagulation system is an aptamer drug and antidote with medium-term duration (~12 hours) that can achieve clinically appropriate activity atrelatively low doses, in combination with a second agent capable of specifically binding to and neutralizaing the primary anticoagulant. Regado Ib is a phase Ib randomized, double-blind, placebocontrolled evaluation of the REG1 Anticoagulation System. Patients aged 50-75 with stable coronaryartery disease, and on oral antiplatelet therapy will be enrolled to evaluate safety of a range of doses of the REG1 anticoagulation system compared to placebo in the target population.
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