Design and rationale of the Evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) trial

Melloni, Chiara; Fier, Ian; Roach, James; Kosinski, Andrzej S.; Broderick, Samuel; Sigmon, Kristina N.; Myles, Shelley K.; Becker, Richard C.; Rao, Sunil V.

doi:10.1016/j.ahj.2009.08.020

Cited by 5 publications

(1 citation statement)

References 20 publications

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“…The EMINENCE phase IIb, multicentre study [Rao et al 2010; Melloni et al 2009] included 503 patients undergoing PCI that were randomized in an open-label fashion to one of three M118 IV dosing arms (50, 75 or 100 IU/kg) or UFH 70 IU/kg as calibrator. The primary end point (composite of death, myocardial infarction, repeat revascularization, stroke, thrombocytopenia, catheter thrombus, bailout use of glycoprotein IIb/IIIa inhibitor, or any bleeding through 30 days) occurred in 22.7%, 28.3% and 30.1% of patients randomized to the M118 doses of 50, 75 and 100 IU/kg, respectively, and in 31.1% of patients randomized to UFH.…”

Section: Indirect Factor Xa Inhibitorsmentioning

confidence: 99%

New parenteral anticoagulants in development

Gómez-Outes

Suárez-Gea

Lecumberri

et al. 2010

Therapeutic Advances in Cardiovascular Disease

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The therapeutic armamentarium of parenteral anticoagulants available to clinicians is mainly composed by unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), fondaparinux, recombinant hirudins (i.e. bivalirudin, desirudin, lepirudin) and argatroban. These drugs are effective and safe for prevention and/or treatment of thromboembolic diseases but they have some drawbacks. Among other inconveniences, UFH requires regular anticoagulant monitoring as a result of variability in the anticoagulant response and there is a risk of serious heparin-induced thrombocytopaenia (HIT). LMWH, fondaparinux and recombinant hirudins are mainly cleared through the kidneys and their use in patients with severe renal insufficiency may be problematic. LMWH is only partially neutralized by protamine while fondaparinux and recombinant hirudins have no specific antidote. Novel anticoagulants in development for parenteral administration include new indirect activated factor Xa (FXa) inhibitors (idrabiotaparinux, ultra-low-molecular-weight heparins [semuloparin, RO-14], new LMWH [M118]), direct FXa inhibitors (otamixaban), direct FIIa inhibitors (flovagatran sodium, pegmusirudin, NU172, HD1-22), direct FXIa inhibitors (BMS-262084, antisense oligonucleotides targeting FXIa, clavatadine), direct FIXa inhibitors (RB-006), FVIIIa inhibitors (TB-402), FVIIa/tissue factor inhibitors (tifacogin, NAPc2, PCI-27483, BMS-593214), FVa inhibitors (drotrecogin alpha activated, ART-123) and dual thrombin/FXa inhibitors (EP217609, tanogitran). These new compounds have the potential to complement established parenteral anticoagulants. In the present review, we discuss the pharmacology of new parenteral anticoagulants, the results of clinical studies, the newly planned or ongoing clinical trials with these compounds, and their potential advantages and drawbacks over existing therapies.

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Section: Indirect Factor Xa Inhibitorsmentioning

confidence: 99%