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
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 oligonucleotid...
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| Veröffentlicht in: | The American heart journal 2011-02, Vol.161 (2), p.261-268.e2 |
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| creator | Povsic, Thomas J., MD, PhD Cohen, Mauricio G., MD Mehran, Roxana, MD Buller, Christopher E., MD Bode, Christoph, MD Cornel, Jan H., MD Kasprzak, Jarosław D., MD Montalescot, Gilles, MD Joseph, Diane Wargin, William A., PhD Rusconi, Christopher P., PhD Zelenkofske, Steven L., DO Becker, Richard C., MD Alexander, John H., MD, MHS |
| description | 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. |
| doi_str_mv | 10.1016/j.ahj.2010.10.022 |
| format | Article |
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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.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2010.10.022</identifier><identifier>PMID: 21315207</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Acute Coronary Syndrome - drug therapy ; Acute coronary syndromes ; Anticoagulants ; Aptamers, Nucleotide - administration & dosage ; Aptamers, Nucleotide - pharmacokinetics ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiovascular ; Clinical Trials, Phase II as Topic - methods ; Coronary heart disease ; Coronary vessels ; Drug therapy ; Heart ; Heart attacks ; Humans ; Medical sciences ; Multicenter Studies as Topic ; Myocarditis. Cardiomyopathies ; Oligonucleotides - administration & dosage ; Oligonucleotides - pharmacokinetics ; Randomized Controlled Trials as Topic - methods</subject><ispartof>The American heart journal, 2011-02, Vol.161 (2), p.261-268.e2</ispartof><rights>Mosby, Inc.</rights><rights>2011 Mosby, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Mosby, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c465t-38ab28b1b21812a7ef839446221099dac87afc77d9806dd1a2ad42f68becb3223</citedby><cites>FETCH-LOGICAL-c465t-38ab28b1b21812a7ef839446221099dac87afc77d9806dd1a2ad42f68becb3223</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1547883428?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,781,785,3551,27926,27927,45997,64387,64389,64391,72471</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23889774$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21315207$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Povsic, Thomas J., MD, PhD</creatorcontrib><creatorcontrib>Cohen, Mauricio G., MD</creatorcontrib><creatorcontrib>Mehran, Roxana, MD</creatorcontrib><creatorcontrib>Buller, Christopher E., MD</creatorcontrib><creatorcontrib>Bode, Christoph, MD</creatorcontrib><creatorcontrib>Cornel, Jan H., MD</creatorcontrib><creatorcontrib>Kasprzak, Jarosław D., MD</creatorcontrib><creatorcontrib>Montalescot, Gilles, MD</creatorcontrib><creatorcontrib>Joseph, Diane</creatorcontrib><creatorcontrib>Wargin, William A., PhD</creatorcontrib><creatorcontrib>Rusconi, Christopher P., PhD</creatorcontrib><creatorcontrib>Zelenkofske, Steven L., DO</creatorcontrib><creatorcontrib>Becker, Richard C., MD</creatorcontrib><creatorcontrib>Alexander, John H., MD, MHS</creatorcontrib><title>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</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>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. 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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.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>21315207</pmid><doi>10.1016/j.ahj.2010.10.022</doi><tpages>8</tpages></addata></record> |
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| subjects | Acute Coronary Syndrome - drug therapy Acute coronary syndromes Anticoagulants Aptamers, Nucleotide - administration & dosage Aptamers, Nucleotide - pharmacokinetics Biological and medical sciences Cardiology. Vascular system Cardiovascular Clinical Trials, Phase II as Topic - methods Coronary heart disease Coronary vessels Drug therapy Heart Heart attacks Humans Medical sciences Multicenter Studies as Topic Myocarditis. Cardiomyopathies Oligonucleotides - administration & dosage Oligonucleotides - pharmacokinetics Randomized Controlled Trials as Topic - methods |
| title | 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 |
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