ACST-1: Difference between revisions

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Halliday A, Harrison M, Hayter E, Kong X, Mansfield A, Marro J, et al. 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. ''Lancet''. 2010 Sep 25;376(9746):1074–84.
==Clinical Question==
==Clinical Question==
<!-- This should be a PICO (Population, Intervention, Comparison, Outcome) style question. As an example, the ACCORD trial's clinical question is shown below, but you should replace it with the clinical question addressed by the trial you're summarizing. -->
<!-- This should be a PICO (Population, Intervention, Comparison, Outcome) style question. As an example, the ACCORD trial's clinical question is shown below, but you should replace it with the clinical question addressed by the trial you're summarizing. -->
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<!-- This section provides a bulleted-list summary of your trial's design. Use the ACCORD trial as a template. Don't worry about the asterisks; they're just bullets for a bulleted list. -->
<!-- This section provides a bulleted-list summary of your trial's design. Use the ACCORD trial as a template. Don't worry about the asterisks; they're just bullets for a bulleted list. -->


* Multicenter, randomized, controlled trial
* Multicenter, blinded, randomized, controlled trial
* N=3,120
* N=3,120
** Intensive (n=5,128)
** immediate CEA (n=1,560)
** Standard (n=5,123)
** deferral of any carotid procedure (n=1,560)
* Setting: 126 centres in 30 countries  
* Setting: 126 centers in 30 countries  
* Enrollment: January to June 2001, February 2003 to October 2005
* Enrollment: April 1993 to July 2003
* Mean follow-up: 3.5 years
* Median follow-up: 9 years
* Analysis: Intention-to-treat
* Analysis: Intention-to-treat
* Primary outcome: perioperative mortality and morbidity (death or stroke within 30 days) and non-perioperative stroke
* Primary outcome: perioperative mortality and morbidity (death or stroke within 30 days) and non-perioperative stroke
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<!-- Ditto for exclusion criteria! -->
<!-- Ditto for exclusion criteria! -->
   
   
* Frequent or recent serious hypoglycemic events
*  
* Unwillingness to perform home glucose monitoring or insulin injections
* BMI >45
* Cr >1.5mg/dl
* Serious illness


===Baseline Characteristics===
===Baseline Characteristics===
<!-- Now summarize what the patients looked like at randomization. An example is shown below, but replace it with the baseline characteristics from the study you're summarizing. -->
<!-- Now summarize what the patients looked like at randomization. An example is shown below, but replace it with the baseline characteristics from the study you're summarizing. -->


* Mean age: 72 years
*  
* Mean BMI: 28
* Mean HbA1c: 8.8%
* Units of insulin: 14 units/day


==Interventions==
==Interventions==
<!-- What were the study's interventions? A bulleted list is a nice way to describe these, hence the asterisks in the ACCORD example below. You should replace that with the relevant interventions from the study you're summarizing. -->
<!-- What were the study's interventions? A bulleted list is a nice way to describe these, hence the asterisks in the ACCORD example below. You should replace that with the relevant interventions from the study you're summarizing. -->


* Randomized to intensive (targeting HbA1c <6%) or standard (HbA1c 7-7.9%) glycemic therapy

*  
** Then 46% were randomized to intensive (SBP <120) vs. standard (SBP <140) blood pressure therapy
** Remaining 54% randomized to fenofibrate vs. placebo; all received statin
* Intensive glycemic control group attended monthly visits for 4 months, then every 2 months, with additional visits and telephone calls as needed
* Standard therapy group had glycemic control visits every 4 months


==Outcomes==
==Outcomes==
1,174

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