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Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY).
MedLine Citation:
PMID:  21095265     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥ 12 months of dual-antiplatelet therapy.
HYPOTHESIS: Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment.
STUDY DESIGN: PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated-balancing randomization-with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization. With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%.
SUMMARY: The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency.
Marco Valgimigli; Gianluca Campo; Gianfranco Percoco; Monia Monti; Fabrizio Ferrari; Carlo Tumscitz; Andrea Zuffi; Federico Colombo; Moh'd Kubbajeh; Caterina Cavazza; Elisa Cangiano; Matteo Tebaldi; Monica Minarelli; Chiara Arcozzi; Antonella Scalone; Alice Frangione; Marco Borghesi; Jlenia Marchesini; Giovanni Parrinello; Roberto Ferrari
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  American heart journal     Volume:  160     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-11-24     Completed Date:  2011-01-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  804-11     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 Mosby, Inc. All rights reserved.
Cardiology Department, University of Ferrara, Ferrara, Italy.
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MeSH Terms
Angioplasty, Balloon, Coronary / methods*
Coronary Disease / drug therapy,  pathology,  surgery*
Coronary Restenosis / etiology,  pathology,  prevention & control*
Coronary Vessels / drug effects,  pathology*
Dose-Response Relationship, Drug
Drug-Eluting Stents / adverse effects*
Follow-Up Studies
Hyperplasia / etiology,  pathology,  prevention & control
Platelet Aggregation Inhibitors / administration & dosage
Ticlopidine / administration & dosage,  analogs & derivatives*
Time Factors
Treatment Outcome
Tunica Intima / drug effects,  pathology*
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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