Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial infarction : the randomized multicentre CASTEMI study
To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48...
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| Veröffentlicht in: | European heart journal 2006-11, Vol.27 (21), p.2516-2523 |
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| creator | BÄR, Frits W TZIVONI, Dan HIBBERD, Mark G KRUCOFF, Mitchell W DIRKSEN, Maurits T FERNANDEZ-ORTIZ, Antonio HEYNDRICKX, Guy R BRACHMANN, Johannes REIBER, Johan H. C AVASTHY, Neelima TATSUNO, Jun DAVIES, Martin |
| description | To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.
This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established. |
| doi_str_mv | 10.1093/eurheartj/ehl304 |
| format | Article |
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STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.
This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.</description><identifier>ISSN: 0195-668X</identifier><identifier>EISSN: 1522-9645</identifier><identifier>DOI: 10.1093/eurheartj/ehl304</identifier><identifier>PMID: 17030521</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Angioplasty, Balloon, Coronary - methods ; Benzenesulfonates - administration & dosage ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiotonic Agents - administration & dosage ; Coronary heart disease ; Diseases of the cardiovascular system ; Female ; Heart ; Humans ; Infusions, Intravenous ; Male ; Medical sciences ; Middle Aged ; Myocardial Infarction - pathology ; Myocardial Infarction - therapy ; Myocarditis. Cardiomyopathies ; Piperazines - administration & dosage ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Treatment Outcome</subject><ispartof>European heart journal, 2006-11, Vol.27 (21), p.2516-2523</ispartof><rights>2006 INIST-CNRS</rights><rights>Copyright Oxford University Press(England) Nov 2006</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c462t-c44ddb8c4ff13a39092363223406e609e9a2d02cb26866db0e30384f121849743</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18237545$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17030521$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BÄR, Frits W</creatorcontrib><creatorcontrib>TZIVONI, Dan</creatorcontrib><creatorcontrib>HIBBERD, Mark G</creatorcontrib><creatorcontrib>KRUCOFF, Mitchell W</creatorcontrib><creatorcontrib>DIRKSEN, Maurits T</creatorcontrib><creatorcontrib>FERNANDEZ-ORTIZ, Antonio</creatorcontrib><creatorcontrib>HEYNDRICKX, Guy R</creatorcontrib><creatorcontrib>BRACHMANN, Johannes</creatorcontrib><creatorcontrib>REIBER, Johan H. C</creatorcontrib><creatorcontrib>AVASTHY, Neelima</creatorcontrib><creatorcontrib>TATSUNO, Jun</creatorcontrib><creatorcontrib>DAVIES, Martin</creatorcontrib><creatorcontrib>CASTEMI Study Group</creatorcontrib><creatorcontrib>on behalf of the CASTEMI Study Group</creatorcontrib><title>Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial infarction : the randomized multicentre CASTEMI study</title><title>European heart journal</title><addtitle>Eur Heart J</addtitle><description>To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.
This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.</description><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Benzenesulfonates - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Cardiology. Vascular system</subject><subject>Cardiotonic Agents - administration & dosage</subject><subject>Coronary heart disease</subject><subject>Diseases of the cardiovascular system</subject><subject>Female</subject><subject>Heart</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - pathology</subject><subject>Myocardial Infarction - therapy</subject><subject>Myocarditis. Cardiomyopathies</subject><subject>Piperazines - administration & dosage</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Treatment Outcome</subject><issn>0195-668X</issn><issn>1522-9645</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkV-LEzEUxQdR3Lr67pMEQdGHcfNv0hnflqHqwhbBreDbkCY325Rp0k0yhfpJ_TimncEFXxK4-Z3DyT1F8ZrgTwQ37AqGsAEZ0vYKNj3D_EkxIxWlZSN49bSYYdJUpRD1r4viRYxbjHEtiHheXJA5ZriiZFb8-QFx6FNE3qC0AWRsiAmp3jqrZI9iGvTx9Cb1dnAq2QOg9rrXMkBCH5ZtWxJWfUTWob1MFlw2GpyGcO-tu0f7YHcyHNEeghqSdOCHiJQP3p2m1iUIh6yx3iHjA7pblYseDvI8WB69kkHbHMI6I4M6Tz-fQwbptN_Z36DRLoe3KpuEU7C71WJ5M4Z-WTwzso_warovi59fFqv2W3n7_etNe31bKi5oyifXel0rbgxhkjW4oUwwShnHAgRuoJFUY6rWVNRC6DUGhlnNDaGk5s2cs8vi_ei7D_5hgJi6nY0K-n78bifqZi4orjL49j9w64fgcraOkqoijNQiQ3iEVPAxBjDdtMOO4O5Uefev8m6sPEveTL7Degf6UTB1nIF3EyBj7tTk7SkbH7masnnFK_YXJxO6_w</recordid><startdate>20061101</startdate><enddate>20061101</enddate><creator>BÄR, Frits W</creator><creator>TZIVONI, Dan</creator><creator>HIBBERD, Mark G</creator><creator>KRUCOFF, Mitchell W</creator><creator>DIRKSEN, Maurits T</creator><creator>FERNANDEZ-ORTIZ, Antonio</creator><creator>HEYNDRICKX, Guy R</creator><creator>BRACHMANN, Johannes</creator><creator>REIBER, Johan H. 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Cardiomyopathies</topic><topic>Piperazines - administration & dosage</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>BÄR, Frits W</creatorcontrib><creatorcontrib>TZIVONI, Dan</creatorcontrib><creatorcontrib>HIBBERD, Mark G</creatorcontrib><creatorcontrib>KRUCOFF, Mitchell W</creatorcontrib><creatorcontrib>DIRKSEN, Maurits T</creatorcontrib><creatorcontrib>FERNANDEZ-ORTIZ, Antonio</creatorcontrib><creatorcontrib>HEYNDRICKX, Guy R</creatorcontrib><creatorcontrib>BRACHMANN, Johannes</creatorcontrib><creatorcontrib>REIBER, Johan H. C</creatorcontrib><creatorcontrib>AVASTHY, Neelima</creatorcontrib><creatorcontrib>TATSUNO, Jun</creatorcontrib><creatorcontrib>DAVIES, Martin</creatorcontrib><creatorcontrib>CASTEMI Study Group</creatorcontrib><creatorcontrib>on behalf of the CASTEMI 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>Calcium & Calcified Tissue Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>European heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BÄR, Frits W</au><au>TZIVONI, Dan</au><au>HIBBERD, Mark G</au><au>KRUCOFF, Mitchell W</au><au>DIRKSEN, Maurits T</au><au>FERNANDEZ-ORTIZ, Antonio</au><au>HEYNDRICKX, Guy R</au><au>BRACHMANN, Johannes</au><au>REIBER, Johan H. C</au><au>AVASTHY, Neelima</au><au>TATSUNO, Jun</au><au>DAVIES, Martin</au><aucorp>CASTEMI Study Group</aucorp><aucorp>on behalf of the CASTEMI Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial infarction : the randomized multicentre CASTEMI study</atitle><jtitle>European heart journal</jtitle><addtitle>Eur Heart J</addtitle><date>2006-11-01</date><risdate>2006</risdate><volume>27</volume><issue>21</issue><spage>2516</spage><epage>2523</epage><pages>2516-2523</pages><issn>0195-668X</issn><eissn>1522-9645</eissn><abstract>To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.
This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>17030521</pmid><doi>10.1093/eurheartj/ehl304</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | European heart journal, 2006-11, Vol.27 (21), p.2516-2523 |
| issn | 0195-668X 1522-9645 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals |
| subjects | Angioplasty, Balloon, Coronary - methods Benzenesulfonates - administration & dosage Biological and medical sciences Cardiology. Vascular system Cardiotonic Agents - administration & dosage Coronary heart disease Diseases of the cardiovascular system Female Heart Humans Infusions, Intravenous Male Medical sciences Middle Aged Myocardial Infarction - pathology Myocardial Infarction - therapy Myocarditis. Cardiomyopathies Piperazines - administration & dosage Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Treatment Outcome |
| title | Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial infarction : the randomized multicentre CASTEMI study |
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