| Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. | |
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MedLine Citation:
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PMID: 19033002 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Antiplatelet therapy with clopidogrel and acetylsalicylic acid (ASA) reduces major cardiovascular events in patients with ST and non-ST-segment-elevation acute coronary syndromes (ACS). Recent mechanistic and clinical data suggest that higher loading and maintenance doses of clopidogrel may achieve a more rapid and greater degree of platelet inhibition that translates into improved clinical outcomes, but this is yet to be formally evaluated in an adequately powered randomized trial. OBJECTIVES: To evaluate the efficacy and safety of (1) a higher loading and initial maintenance dose of clopidogrel compared with the standard-dose regimen and (2) high-dose ASA compared with low-dose ASA in patients with ST or non-ST-segment-elevation ACS managed with an early invasive strategy. DESIGN: Multicenter, international, randomized, 2 x 2 factorial design trial evaluating a clopidogrel high-dose regimen (600 mg loading dose on day 1 followed by 150 mg once daily on days 2 to 7, followed by 75 mg once daily on days 8-30) compared with the standard-dose regimen (300 mg loading dose on day 1, followed by 75 mg once daily on days 2-30) and high-dose ASA (300-325 mg daily) versus low-dose ASA (75-100 mg daily) in patients with ST or non-ST-segment-elevation ACS managed with an early invasive strategy. The clopidogrel dose comparison is double-blind and the ASA dose comparison is open-label. The primary outcome is the composite of death from cardiovascular causes, myocardial (re)infarction or stroke up to day 30. The primary safety outcome is major bleeding. The sample size is 18,000 to 20,000 patients. CONCLUSIONS: The CURRENT-OASIS 7 trial will help to define optimal dosing regimens for clopidogrel and ASA in patients with ST and non-ST-segment-elevation ACS treated with an early invasive strategy. |
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Authors:
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Shamir R Mehta; Jean-Pierre Bassand; Susan Chrolavicius; Rafael Diaz; Keith A A Fox; Christopher B Granger; Sanjit Jolly; Hans-Jurgen Rupprecht; Petr Widimsky; Salim Yusuf; |
Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial Date: 2008-11-01 |
Journal Detail:
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Title: American heart journal Volume: 156 ISSN: 1097-6744 ISO Abbreviation: Am. Heart J. Publication Date: 2008 Dec |
Date Detail:
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Created Date: 2008-11-26 Completed Date: 2008-12-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0370465 Medline TA: Am Heart J Country: United States |
Other Details:
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Languages: eng Pagination: 1080-1088.e1 Citation Subset: AIM; IM |
Affiliation:
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McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. smehta@mcmaster.ca |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00335452 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acute Coronary Syndrome
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drug therapy*,
mortality,
radiography Adult Aged Angioplasty, Transluminal, Percutaneous Coronary Aspirin / administration & dosage*, adverse effects Cause of Death Combined Modality Therapy Coronary Angiography Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Electrocardiography / drug effects* Female Follow-Up Studies Hemorrhage / chemically induced Humans Male Middle Aged Myocardial Infarction / drug therapy, mortality, radiography Platelet Aggregation Inhibitors / administration & dosage*, adverse effects Recurrence Stroke / mortality Ticlopidine / administration & dosage, adverse effects, analogs & derivatives* Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel |
| Investigator | |
Investigator/Affiliation:
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S R Mehta / ; A Ajani / ; A Avezum / ; J P Bassand / ; W E Boden / ; A Budaj / ; E Cardona / ; S Chrolavicius / ; J Col / ; P Commerford / ; G Di Pasquale / ; R Diaz / ; J Eha / ; J W Eikelboom / ; D P Faxon / ; M Flather / ; D Foley / ; K A A Fox / ; M G Franzosi / ; C B Granger / ; Milan Gupta / ; S Jolly / ; C Joyner / ; N Karatzas / ; A Kastrati / ; J H Kim / ; T H Koh / ; F Lanas / ; B Lewis / ; C Macaya / ; T Moccetti / ; G Montalescot / ; K Niemela / ; Z Ongen / ; A Orlandini / ; P Pais / ; R J G Peters / ; L Piegas / ; J Probstfield / ; J Rankin / ; M Ruda / ; Z Rumboldt / ; H J Rupprecht / ; P G Steg / ; Jean-Francois Tanguay / ; V Valentin / ; J Varigos / ; H White / ; P Widimsky / ; D Xavier / ; S Yusuf / ; J Zhu / ; J-R Zhu / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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