Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study
Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We con...
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Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2002-02, Vol.105 (5), p.557-563 |
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creator | FIORE, Louis D EZEKOWITZ, Michael D BROPHY, Mary T LU, David SACCO, Joseph PEDUZZI, Peter |
description | Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P |
doi_str_mv | 10.1161/hc0502.103329 |
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In post-myocardial infarction patients, warfarin therapy (at a mean international normalized ratio of 1.8) combined with low-dose aspirin did not provide a clinical benefit beyond that achievable with aspirin monotherapy.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/hc0502.103329</identifier><identifier>PMID: 11827919</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Anti-Inflammatory Agents, Non-Steroidal - adverse effects ; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use ; Anticoagulants - adverse effects ; Anticoagulants - therapeutic use ; Aspirin - adverse effects ; Aspirin - therapeutic use ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Hemorrhage - etiology ; Hospitals, Veterans ; Humans ; International Normalized Ratio - statistics & numerical data ; Male ; Medical sciences ; Middle Aged ; Myocardial Infarction - drug therapy ; Pharmacology. Drug treatments ; Proportional Hazards Models ; Risk Assessment ; Survival Rate ; Treatment Outcome ; United States ; Warfarin - adverse effects ; Warfarin - therapeutic use</subject><ispartof>Circulation (New York, N.Y.), 2002-02, Vol.105 (5), p.557-563</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright American Heart Association, Inc. Feb 5, 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c343t-d840a0e87de8c87e7c05782d7f66b683f940111a071119c851c811dd1681f6bb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13477061$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11827919$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>FIORE, Louis D</creatorcontrib><creatorcontrib>EZEKOWITZ, Michael D</creatorcontrib><creatorcontrib>BROPHY, Mary T</creatorcontrib><creatorcontrib>LU, David</creatorcontrib><creatorcontrib>SACCO, Joseph</creatorcontrib><creatorcontrib>PEDUZZI, Peter</creatorcontrib><creatorcontrib>Combination Hemotherapy and Mortality Prevention (CHAMP) Study Group</creatorcontrib><title>Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P<0.001). There were 14 individuals with intracranial bleeds in both the aspirin and combination therapy groups.
In post-myocardial infarction patients, warfarin therapy (at a mean international normalized ratio of 1.8) combined with low-dose aspirin did not provide a clinical benefit beyond that achievable with aspirin monotherapy.</description><subject>Anti-Inflammatory Agents, Non-Steroidal - adverse effects</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</subject><subject>Anticoagulants - adverse effects</subject><subject>Anticoagulants - therapeutic use</subject><subject>Aspirin - adverse effects</subject><subject>Aspirin - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hemorrhage - etiology</subject><subject>Hospitals, Veterans</subject><subject>Humans</subject><subject>International Normalized Ratio - statistics & numerical data</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - drug therapy</subject><subject>Pharmacology. Drug treatments</subject><subject>Proportional Hazards Models</subject><subject>Risk Assessment</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Warfarin - adverse effects</subject><subject>Warfarin - therapeutic use</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkU1v1DAQhi1ERZeFI1dkIXFM64mT2OFWLR9FatUe4Bw5_ui6SuxgO1vt_-QH4TQrehnPjB69M54XoQ9ALgAauNxLUpPyAgilZfsKbaAuq6KqafsabQghbcFoWZ6jtzE-5rKhrH6DzgF4yVpoN-jvVz2JkEbtEvYGH3TSQbiIhTHChoil91PuJHvQOKZZWR3xFPxDECOWg3VWigGnYHOUfsxS1j0sWW-dVvhJBLO0sHAKizjZJX-yaf-_EIN3GuckzuFgDz6PzGsIOSeNx6OXIqhF27qsI5P17gu-D3YU4YiDjvOQnvm013h3fXV7_7zj8R06M2KI-v3p3aLf37_92l0XN3c_fu6ubgpJK5oKxSsiiOZMaS450yyfkvFSMdM0fcOpaSsCAIKwHFvJa5AcQCloOJim7-kWfVp180X-zDqm7tHPweWRXQklq4FnW7aoWCEZfIxBm25aP9AB6RYLu9XCbrUw8x9PonM_avVCnzzLwOcTIGK-vsl-SRtfOFoxRhqg_wCFXKic</recordid><startdate>20020205</startdate><enddate>20020205</enddate><creator>FIORE, Louis D</creator><creator>EZEKOWITZ, Michael D</creator><creator>BROPHY, Mary T</creator><creator>LU, David</creator><creator>SACCO, Joseph</creator><creator>PEDUZZI, Peter</creator><general>Lippincott Williams & Wilkins</general><general>American Heart Association, Inc</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>U9A</scope></search><sort><creationdate>20020205</creationdate><title>Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study</title><author>FIORE, Louis D ; EZEKOWITZ, Michael D ; BROPHY, Mary T ; LU, David ; SACCO, Joseph ; PEDUZZI, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c343t-d840a0e87de8c87e7c05782d7f66b683f940111a071119c851c811dd1681f6bb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Anti-Inflammatory Agents, Non-Steroidal - adverse effects</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</topic><topic>Anticoagulants - adverse effects</topic><topic>Anticoagulants - therapeutic use</topic><topic>Aspirin - adverse effects</topic><topic>Aspirin - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hemorrhage - etiology</topic><topic>Hospitals, Veterans</topic><topic>Humans</topic><topic>International Normalized Ratio - statistics & numerical data</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - drug therapy</topic><topic>Pharmacology. Drug treatments</topic><topic>Proportional Hazards Models</topic><topic>Risk Assessment</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Warfarin - adverse effects</topic><topic>Warfarin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>FIORE, Louis D</creatorcontrib><creatorcontrib>EZEKOWITZ, Michael D</creatorcontrib><creatorcontrib>BROPHY, Mary T</creatorcontrib><creatorcontrib>LU, David</creatorcontrib><creatorcontrib>SACCO, Joseph</creatorcontrib><creatorcontrib>PEDUZZI, Peter</creatorcontrib><creatorcontrib>Combination Hemotherapy and Mortality Prevention (CHAMP) Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>FIORE, Louis D</au><au>EZEKOWITZ, Michael D</au><au>BROPHY, Mary T</au><au>LU, David</au><au>SACCO, Joseph</au><au>PEDUZZI, Peter</au><aucorp>Combination Hemotherapy and Mortality Prevention (CHAMP) Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2002-02-05</date><risdate>2002</risdate><volume>105</volume><issue>5</issue><spage>557</spage><epage>563</epage><pages>557-563</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><coden>CIRCAZ</coden><abstract>Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P<0.001). There were 14 individuals with intracranial bleeds in both the aspirin and combination therapy groups.
In post-myocardial infarction patients, warfarin therapy (at a mean international normalized ratio of 1.8) combined with low-dose aspirin did not provide a clinical benefit beyond that achievable with aspirin monotherapy.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>11827919</pmid><doi>10.1161/hc0502.103329</doi><tpages>7</tpages></addata></record> |
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source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete |
subjects | Anti-Inflammatory Agents, Non-Steroidal - adverse effects Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Anticoagulants - adverse effects Anticoagulants - therapeutic use Aspirin - adverse effects Aspirin - therapeutic use Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system Drug Therapy, Combination Female Follow-Up Studies Hemorrhage - etiology Hospitals, Veterans Humans International Normalized Ratio - statistics & numerical data Male Medical sciences Middle Aged Myocardial Infarction - drug therapy Pharmacology. Drug treatments Proportional Hazards Models Risk Assessment Survival Rate Treatment Outcome United States Warfarin - adverse effects Warfarin - therapeutic use |
title | Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study |
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