Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post–Percutaneous Coronary Intervention (RIVER-PCI) trial

Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic...

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Veröffentlicht in:The American heart journal 2013-12, Vol.166 (6), p.953-959.e3
Hauptverfasser: Weisz, Giora, MD, Farzaneh-Far, Ramin, MD, Ben-Yehuda, Ori, MD, DeBruyne, Bernard, MD, Montalescot, Gilles, MD, PhD, Lerman, Amir, MD, Mahmud, Ehtisham, MD, Alexander, Karen P., MD, Ohman, E. Magnus, MD, White, Harvey D., DSc, Olmsted, Ann, PhD, Walker, Gennyne A., PhD, Stone, Gregg W., MD
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container_end_page 959.e3
container_issue 6
container_start_page 953
container_title The American heart journal
container_volume 166
creator Weisz, Giora, MD
Farzaneh-Far, Ramin, MD
Ben-Yehuda, Ori, MD
DeBruyne, Bernard, MD
Montalescot, Gilles, MD, PhD
Lerman, Amir, MD
Mahmud, Ehtisham, MD
Alexander, Karen P., MD
Ohman, E. Magnus, MD
White, Harvey D., DSc
Olmsted, Ann, PhD
Walker, Gennyne A., PhD
Stone, Gregg W., MD
description Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.
doi_str_mv 10.1016/j.ahj.2013.08.004
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Magnus, MD ; White, Harvey D., DSc ; Olmsted, Ann, PhD ; Walker, Gennyne A., PhD ; Stone, Gregg W., MD</creator><creatorcontrib>Weisz, Giora, MD ; Farzaneh-Far, Ramin, MD ; Ben-Yehuda, Ori, MD ; DeBruyne, Bernard, MD ; Montalescot, Gilles, MD, PhD ; Lerman, Amir, MD ; Mahmud, Ehtisham, MD ; Alexander, Karen P., MD ; Ohman, E. Magnus, MD ; White, Harvey D., DSc ; Olmsted, Ann, PhD ; Walker, Gennyne A., PhD ; Stone, Gregg W., MD</creatorcontrib><description>Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2013.08.004</identifier><identifier>PMID: 24268208</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Acetanilides - therapeutic use ; Angina Pectoris - therapy ; Cardiology ; Cardiovascular ; Coronary vessels ; Double-Blind Method ; Enzyme Inhibitors - therapeutic use ; Female ; Heart attacks ; Hospitalization - statistics &amp; numerical data ; Humans ; Male ; Mortality ; Percutaneous Coronary Intervention ; Piperazines - therapeutic use ; Quality of Life ; Ranolazine ; Retreatment - statistics &amp; numerical data ; Treatment Outcome</subject><ispartof>The American heart journal, 2013-12, Vol.166 (6), p.953-959.e3</ispartof><rights>Mosby, Inc.</rights><rights>2013 Mosby, Inc.</rights><rights>2013.</rights><rights>Copyright Elsevier Limited Dec 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-92eb44f2b0eab233816260298405eeede1940d0c166000b6f641e5cacecf89423</citedby><cites>FETCH-LOGICAL-c436t-92eb44f2b0eab233816260298405eeede1940d0c166000b6f641e5cacecf89423</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870313005280$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24268208$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Weisz, Giora, MD</creatorcontrib><creatorcontrib>Farzaneh-Far, Ramin, MD</creatorcontrib><creatorcontrib>Ben-Yehuda, Ori, MD</creatorcontrib><creatorcontrib>DeBruyne, Bernard, MD</creatorcontrib><creatorcontrib>Montalescot, Gilles, MD, PhD</creatorcontrib><creatorcontrib>Lerman, Amir, MD</creatorcontrib><creatorcontrib>Mahmud, Ehtisham, MD</creatorcontrib><creatorcontrib>Alexander, Karen P., MD</creatorcontrib><creatorcontrib>Ohman, E. Magnus, MD</creatorcontrib><creatorcontrib>White, Harvey D., DSc</creatorcontrib><creatorcontrib>Olmsted, Ann, PhD</creatorcontrib><creatorcontrib>Walker, Gennyne A., PhD</creatorcontrib><creatorcontrib>Stone, Gregg W., MD</creatorcontrib><title>Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post–Percutaneous Coronary Intervention (RIVER-PCI) trial</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. 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Magnus, MD</au><au>White, Harvey D., DSc</au><au>Olmsted, Ann, PhD</au><au>Walker, Gennyne A., PhD</au><au>Stone, Gregg W., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post–Percutaneous Coronary Intervention (RIVER-PCI) trial</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2013-12-01</date><risdate>2013</risdate><volume>166</volume><issue>6</issue><spage>953</spage><epage>959.e3</epage><pages>953-959.e3</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>24268208</pmid><doi>10.1016/j.ahj.2013.08.004</doi></addata></record>
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subjects Acetanilides - therapeutic use
Angina Pectoris - therapy
Cardiology
Cardiovascular
Coronary vessels
Double-Blind Method
Enzyme Inhibitors - therapeutic use
Female
Heart attacks
Hospitalization - statistics & numerical data
Humans
Male
Mortality
Percutaneous Coronary Intervention
Piperazines - therapeutic use
Quality of Life
Ranolazine
Retreatment - statistics & numerical data
Treatment Outcome
title Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post–Percutaneous Coronary Intervention (RIVER-PCI) trial
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