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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.

Abstract
Anticoagulants are the cornerstone of current acute coronary syndrome (ACS) therapy; however, anticoagulation regimens that aggressively reduce ischemic events are almost uniformly associated with more bleeding. REG1, an anticoagulation system, consists of RB006 (pegnivacogin), an RNA oligonucleotide factor IXa inhibitor, and RB007 (anivamersen), its complementary controlling agent. Phase I and IIa studies defined predictable relationships between doses of RB006, RB007, and degree of antifactor IX activity. The efficacy and safety of REG1 for the treatment of patients with ACS managed invasively and the safety of reversing RB006 with RB007 after cardiac catheterization are unknown. Randomized, partially-blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system compared to unfractionated heparin or low molecular heparin in subjects with acute coronary syndrome (RADAR) is designed to assess both the efficacy of the anticoagulant RB006 and the safety of a range of levels of RB006 reversal with RB007. The objectives of RADAR are (1) to determine the safety of a range of levels of RB006 reversal with RB007 after catheterization, (2) to confirm whether a dose of 1 mg/kg RB006 results in near-complete inhibition of factor IXa in patients with ACS, and (3) to assess the efficacy of RB006 as an anticoagulant in patients with ACS undergoing percutaneous coronary intervention.
AuthorsThomas J Povsic, Mauricio G Cohen, Roxana Mehran, Christopher E Buller, Christoph Bode, Jan H Cornel, Jarosław D Kasprzak, Gilles Montalescot, Diane Joseph, William A Wargin, Christopher P Rusconi, Steven L Zelenkofske, Richard C Becker, John H Alexander
JournalAmerican heart journal (Am Heart J) Vol. 161 Issue 2 Pg. 261-268.e1-2 (Feb 2011) ISSN: 1097-6744 [Electronic] United States
PMID21315207 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 Mosby, Inc. All rights reserved.
Chemical References
  • Aptamers, Nucleotide
  • Oligonucleotides
  • RB 006
  • RB 007
Topics
  • Acute Coronary Syndrome (drug therapy)
  • Aptamers, Nucleotide (administration & dosage, pharmacokinetics)
  • Clinical Trials, Phase II as Topic (methods)
  • Humans
  • Multicenter Studies as Topic
  • Oligonucleotides (administration & dosage, pharmacokinetics)
  • Randomized Controlled Trials as Topic (methods)

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