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See also:

  • All cardiovascular prevention clinical trials
  • All post stroke clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of atorvastatin
  •  
     SPARCL study, 2006 TRC4661 
    [NCT00147602] download pdf: atorvastatin | cholesterol lowering intervention for post stroke

    Treatments

    Studied treatment atorvastatin 80mg daily
    Control treatment placebo

    Patients

    Patients patients who had had a stroke or TIA within one to six months before study entry, had low-density lipoprotein (LDL) cholesterol levels of 2.6 to 4.9 mmol per liter, and had no known coronary heart disease
    Baseline characteristics
    Age, yr 62.7 
    male (%) 59.6 
    stroke as entry event (%) 69.1 
    TIA as entry event (%) 30.9 
    Time since entry event, days 85.7 
    baseline total cholesterol (mg/dL) 211.9 
    baseline LDL cholesterol (mg/dl) 133.2 
    baseline HDL cholesterol (mg/dl) 50 
    baseline triglyceridess (mg/dl) 143.7 

    Method and design

    Randomized effectives 2365 / 2366 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 4.9y (median)
    Lost to follow-up 0.53%
    Hypothesis Superiority
    Primary endpoint nonfatal or fatal stroke


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Fatal stroke

    24 / 2365
    41 / 2366
    0,59 [0,36;0,97]

    cardiovascular events

    334 / 2365
    407 / 2366
    0,82 [0,72;0,94]

    Non fatal stroke

    247 / 2365
    280 / 2366
    0,88 [0,75;1,04]

    Coronary event

    81 / 2365
    120 / 2366
    0,68 [0,51;0,89]

    Cardiovascular death

    78 / 2365
    98 / 2366
    0,80 [0,59;1,07]

    stroke (fatal and non fatal)

    265 / 2365
    311 / 2366
    0,85 [0,73;0,99]

    TIA

    153 / 2365
    208 / 2366
    0,74 [0,60;0,90]

    All cause death

    216 / 2365
    211 / 2366
    1,02 [0,85;1,23]

    stroke or TIA

    375 / 2365
    476 / 2366
    0,79 [0,70;0,89]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Fatal stroke 24 / 2365 (1,0%) 41 / 2366 (1,7%) 0,59 [0,36;0,97]  
    cardiovascular events 334 / 2365 (14,1%) 407 / 2366 (17,2%) 0,82 [0,72;0,94]  
    Non fatal stroke 247 / 2365 (10,4%) 280 / 2366 (11,8%) 0,88 [0,75;1,04]  
    Coronary event 81 / 2365 (3,4%) 120 / 2366 (5,1%) 0,68 [0,51;0,89]  
    Cardiovascular death 78 / 2365 (3,3%) 98 / 2366 (4,1%) 0,80 [0,59;1,07]  
    stroke (fatal and non fatal) 265 / 2365 (11,2%) 311 / 2366 (13,1%) 0,85 [0,73;0,99]  
    TIA 153 / 2365 (6,5%) 208 / 2366 (8,8%) 0,74 [0,60;0,90]  
    All cause death 216 / 2365 (9,1%) 211 / 2366 (8,9%) 1,02 [0,85;1,23]  
    stroke or TIA 375 / 2365 (15,9%) 476 / 2366 (20,1%) 0,79 [0,70;0,89]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 4.9y (median))
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Fatal stroke 1,01% 1,73% -0,72%
    cardiovascular events 14,12% 17,20% -3,08%
    Non fatal stroke 10,44% 11,83% -1,39%
    Coronary event 3,42% 5,07% -1,65%
    Cardiovascular death 3,30% 4,14% -0,84%
    stroke (fatal and non fatal) 11,21% 13,14% -1,94%
    TIA 6,47% 8,79% -2,32%
    All cause death 9,13% 8,92% 0,22%
    stroke or TIA 15,86% 20,12% -4,26%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for post stroke (or TIA)

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in post stroke for all type of patients



    Reference(s)

    TrialResults-center ID TRC4661
    Trials register # NCT00147602
    Study web site link http://www.strokecenter.org/trials/TrialDetail.aspx?tid=67
    • Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA. High-dose atorvastatin after stroke or transient ischemic attack.. N Engl J Med 2006 Aug 10;355:549-59
      Pubmed | Hubmed | Fulltext
    • Amarenco P, Benavente O, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, Gilbert S, Rudolph AE, Simunovic L, Zivin JA, Welch KM. Results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial by stroke subtypes.. Stroke 2009;40:1405-9
      Pubmed | Hubmed | Fulltext

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