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Items: 1 to 20 of 31

1.

Pre-existing anti-PEG antibodies are associated with severe immediate allergic reactions to pegnivacogin, a PEGylated aptamer.

Povsic TJ, Lawrence MG, Lincoff AM, Mehran R, Rusconi CP, Zelenkofske SL, Huang Z, Sailstad J, Armstrong PW, Steg PG, Bode C, Becker RC, Alexander JH, Adkinson NF, Levinson AI; REGULATE-PCI Investigators.

J Allergy Clin Immunol. 2016 Jul 14. pii: S0091-6749(16)30605-4. doi: 10.1016/j.jaci.2016.04.058. [Epub ahead of print] No abstract available.

PMID:
27522158
2.

Pre-existing anti-polyethylene glycol antibody linked to first-exposure allergic reactions to pegnivacogin, a PEGylated RNA aptamer.

Ganson NJ, Povsic TJ, Sullenger BA, Alexander JH, Zelenkofske SL, Sailstad JM, Rusconi CP, Hershfield MS.

J Allergy Clin Immunol. 2016 May;137(5):1610-1613.e7. doi: 10.1016/j.jaci.2015.10.034. Epub 2015 Dec 11. No abstract available.

3.

Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial.

Lincoff AM, Mehran R, Povsic TJ, Zelenkofske SL, Huang Z, Armstrong PW, Steg PG, Bode C, Cohen MG, Buller C, Laanmets P, Valgimigli M, Marandi T, Fridrich V, Cantor WJ, Merkely B, Lopez-Sendon J, Cornel JH, Kasprzak JD, Aschermann M, Guetta V, Morais J, Sinnaeve PR, Huber K, Stables R, Sellers MA, Borgman M, Glenn L, Levinson AI, Lopes RD, Hasselblad V, Becker RC, Alexander JH; REGULATE-PCI Investigators.

Lancet. 2016 Jan 23;387(10016):349-56. doi: 10.1016/S0140-6736(15)00515-2. Epub 2015 Nov 5. Erratum in: Lancet. 2016 Mar 19;387(10024):1162. Boudoulas, Dean [corrected to Boudoulas, Konstantinos D.].

PMID:
26547100
4.

Inhibition of factor IXa by the pegnivacogin system during cardiopulmonary bypass: a potential substitute for heparin. A study in baboons.

Bel A, Borik W, Davidson S, Helies JM, Stimmer L, Fremes S, Zelenkofske S, Rusconi C, Alexander J, Alexander D, Menasché P, Pepper J.

Eur J Cardiothorac Surg. 2016 Feb;49(2):682-9. doi: 10.1093/ejcts/ezv159. Epub 2015 May 7.

PMID:
25953802
5.

Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study.

Povsic TJ, Vavalle JP, Alexander JH, Aberle LH, Zelenkofske SL, Becker RC, Buller CE, Cohen MG, Cornel JH, Kasprzak JD, Montalescot G, Fail PS, Sarembock IJ, Mehran R; RADAR Investigators.

EuroIntervention. 2014 Aug;10(4):431-8. doi: 10.4244/EIJY14M06_01.

6.

The effect of the REG2 Anticoagulation System on thrombin generation kinetics: a pharmacodynamic and pharmacokinetic first-in-human study.

Vavalle JP, Rusconi CP, Zelenkofske S, Wargin WA, Ortel TL, Alexander JH, Povsic TJ, Becker RC.

J Thromb Thrombolysis. 2014 Oct;38(3):275-84. doi: 10.1007/s11239-014-1081-6.

PMID:
24880800
7.

Safety of very early sheath removal in patients treated with REG1 for acute coronary syndromes: insights from the RADAR trial.

Vavalle JP, Povsic TJ, Aberle LH, Zelenkofske SL, Mehran R, Kasprzak JD, Bode C, Buller CE, Montalescot G, Cornel JH, Becker RC, Alexander JH, Cohen MG.

J Invasive Cardiol. 2013 Nov;25(11):593-9.

8.

A Phase 2, randomized, partially blinded, active-controlled study assessing the efficacy and safety of variable anticoagulation reversal using the REG1 system in patients with acute coronary syndromes: results of the RADAR trial.

Povsic TJ, Vavalle JP, Aberle LH, Kasprzak JD, Cohen MG, Mehran R, Bode C, Buller CE, Montalescot G, Cornel JH, Rynkiewicz A, Ring ME, Zeymer U, Natarajan M, Delarche N, Zelenkofske SL, Becker RC, Alexander JH; RADAR Investigators.

Eur Heart J. 2013 Aug;34(31):2481-9. doi: 10.1093/eurheartj/ehs232. Epub 2012 Aug 2.

9.

A phase 1 ascending dose study of a subcutaneously administered factor IXa inhibitor and its active control agent.

Vavalle JP, Rusconi CP, Zelenkofske S, Wargin WA, Alexander JH, Becker RC.

J Thromb Haemost. 2012 Jul;10(7):1303-11. doi: 10.1111/j.1538-7836.2012.04742.x.

10.

Pegnivacogin results in near complete FIX inhibition in acute coronary syndrome patients: RADAR pharmacokinetic and pharmacodynamic substudy.

Povsic TJ, Wargin WA, Alexander JH, Krasnow J, Krolick M, Cohen MG, Mehran R, Buller CE, Bode C, Zelenkofske SL, Rusconi CP, Becker RC; RADAR Investigators.

Eur Heart J. 2011 Oct;32(19):2412-9. doi: 10.1093/eurheartj/ehr179. Epub 2011 Jun 30.

11.

Dose selection for a direct and selective factor IXa inhibitor and its complementary reversal agent: translating pharmacokinetic and pharmacodynamic properties of the REG1 system to clinical trial design.

Povsic TJ, Cohen MG, Chan MY, Zelenkofske SL, Wargin WA, Harrington RA, Alexander JH, Rusconi CP, Becker RC.

J Thromb Thrombolysis. 2011 Jul;32(1):21-31. doi: 10.1007/s11239-011-0588-3.

PMID:
21503856
12.

A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial.

Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH, Kasprzak JD, Montalescot G, Joseph D, Wargin WA, Rusconi CP, Zelenkofske SL, Becker RC, Alexander JH.

Am Heart J. 2011 Feb;161(2):261-268.e1-2. doi: 10.1016/j.ahj.2010.10.022.

PMID:
21315207
13.

Translating nucleic acid aptamers to antithrombotic drugs in cardiovascular medicine.

Povsic TJ, Sullenger BA, Zelenkofske SL, Rusconi CP, Becker RC.

J Cardiovasc Transl Res. 2010 Dec;3(6):704-16. doi: 10.1007/s12265-010-9230-6. Epub 2010 Nov 16. Review.

PMID:
21080135
14.

First clinical application of an actively reversible direct factor IXa inhibitor as an anticoagulation strategy in patients undergoing percutaneous coronary intervention.

Cohen MG, Purdy DA, Rossi JS, Grinfeld LR, Myles SK, Aberle LH, Greenbaum AB, Fry E, Chan MY, Tonkens RM, Zelenkofske S, Alexander JH, Harrington RA, Rusconi CP, Becker RC.

Circulation. 2010 Aug 10;122(6):614-22. doi: 10.1161/CIRCULATIONAHA.109.927756. Epub 2010 Jul 26.

15.

Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both.

Pouleur AC, Barkoudah E, Uno H, Skali H, Finn PV, Zelenkofske SL, Belenkov YN, Mareev V, Velazquez EJ, Rouleau JL, Maggioni AP, Køber L, Califf RM, McMurray JJ, Pfeffer MA, Solomon SD; VALIANT Investigators.

Circulation. 2010 Aug 10;122(6):597-602. doi: 10.1161/CIRCULATIONAHA.110.940619. Epub 2010 Jul 26.

16.
17.

Coagulation factor IXa as a target for treatment and prophylaxis of venous thromboembolism.

Eikelboom JW, Zelenkofske SL, Rusconi CP.

Arterioscler Thromb Vasc Biol. 2010 Mar;30(3):382-7. doi: 10.1161/ATVBAHA.110.203117. Epub 2010 Feb 5. Review.

18.

Left atrial remodelling in patients with myocardial infarction complicated by heart failure, left ventricular dysfunction, or both: the VALIANT Echo study.

Meris A, Amigoni M, Uno H, Thune JJ, Verma A, Køber L, Bourgoun M, McMurray JJ, Velazquez EJ, Maggioni AP, Ghali J, Arnold JM, Zelenkofske S, Pfeffer MA, Solomon SD.

Eur Heart J. 2009 Jan;30(1):56-65. doi: 10.1093/eurheartj/ehn499. Epub 2008 Nov 11.

19.

Effect of antecedent hypertension and follow-up blood pressure on outcomes after high-risk myocardial infarction.

Thune JJ, Signorovitch J, Kober L, Velazquez EJ, McMurray JJ, Califf RM, Maggioni AP, Rouleau JL, Howlett J, Zelenkofske S, Pfeffer MA, Solomon SD.

Hypertension. 2008 Jan;51(1):48-54. Epub 2007 Nov 19.

20.

Albuminuria response to very high-dose valsartan in type 2 diabetes mellitus.

Hollenberg NK, Parving HH, Viberti G, Remuzzi G, Ritter S, Zelenkofske S, Kandra A, Daley WL, Rocha R.

J Hypertens. 2007 Sep;25(9):1921-6.

PMID:
17762658
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