Clopidogrel dosing and role of genetics: ELEVATE-TIMI 56 trial: Difference between revisions

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(/* ELEVATE-TIMI 56 trial {{cite journal| author=Mega JL, Hochholzer W, Frelinger AL, Kluk MJ, Angiolillo DJ, Kereiakes DJ et al.| title=Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiov)
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==ELEVATE-TIMI 56 trial <ref name="pmid22088980">{{cite journal| author=Mega JL, Hochholzer W, Frelinger AL, Kluk MJ, Angiolillo DJ, Kereiakes DJ et al.| title=Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease. | journal=JAMA | year= 2011 | volume= 306 | issue= 20 | pages= 2221-8 | pmid=22088980 | doi=10.1001/jama.2011.1703 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=22088980  }} </ref> ==
==ELEVATE-TIMI 56 trial <ref name="pmid22088980">{{cite journal| author=Mega JL, Hochholzer W, Frelinger AL, Kluk MJ, Angiolillo DJ, Kereiakes DJ et al.| title=Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease. | journal=JAMA | year= 2011 | volume= 306 | issue= 20 | pages= 2221-8 | pmid=22088980 | doi=10.1001/jama.2011.1703 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=22088980  }} </ref> ==


* '''Hypothesis''' -  
* '''Hypothesis''' - To see whether increasing the dose of clopidogrel to 300 mg / day rather than the standard 75 mg / day maintenance dose improves outcomes in patients with loss-of-function CYP2C19 genotypes.
* '''Study design'''
* '''Study design'''
** '''Patient population'''   
** '''Patient population'''   
*** Multicenter, randomized, double-blind trial
*** Multicenter, randomized, double-blind trial
*** Duration of study - 1 years
*** Duration of study - 1 years
*** Intervention -
*** Intervention - Maintenance doses of clopidogrel for 4 treatment periods, (each treatment period lasted 14 days). 247 noncarriers received 75 and 150 mg daily of clopidogrel (2 periods each), and 86 carriers (80 heterozygotes, 6 homozygotes) received 75, 150, 225, and 300 mg daily.
*** Primary end point -  
*** Primary end point - Platelet function test results and adverse events.


* '''Limitations'''
* '''Limitations'''

Revision as of 14:54, 25 November 2011

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Priyamvada Singh, M.B.B.S. [2]

Overview

The results of the ELEVATE-TIMI 56 trial were recently presented in AHA 2011 held at Orlando, Florida.

ELEVATE-TIMI 56 trial [1]

  • Hypothesis - To see whether increasing the dose of clopidogrel to 300 mg / day rather than the standard 75 mg / day maintenance dose improves outcomes in patients with loss-of-function CYP2C19 genotypes.
  • Study design
    • Patient population
      • Multicenter, randomized, double-blind trial
      • Duration of study - 1 years
      • Intervention - Maintenance doses of clopidogrel for 4 treatment periods, (each treatment period lasted 14 days). 247 noncarriers received 75 and 150 mg daily of clopidogrel (2 periods each), and 86 carriers (80 heterozygotes, 6 homozygotes) received 75, 150, 225, and 300 mg daily.
      • Primary end point - Platelet function test results and adverse events.
  • Limitations
  • Results -
  • Conclusions

References

  1. Mega JL, Hochholzer W, Frelinger AL, Kluk MJ, Angiolillo DJ, Kereiakes DJ; et al. (2011). "Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease". JAMA. 306 (20): 2221–8. doi:10.1001/jama.2011.1703. PMID 22088980.


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