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See also:

  • All acute coronary syndrome clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of ticagrelor + aspirin
    		•  

    PLATO study, 2009

    [NCT00391872]

    Treatments

    Studied treatment ticagrelor 90mg twice daily
    oral loading dose of ticagrelor 180 mg
    Control treatment clopidogrel 75mg once daily
    oral loading dose of clopidogrel 300 mg
    Concomittant treatment All patients received acetylsalicylic acid (aspirin) at a dose of 75 to 100 mg daily unless they could not tolerate the drug.
    Remarks Patients undergoing PCI after randomization received, in a blind fashion, an additional dose of their study drug at the time of PCI

    Patients

    Patients patients with an acute coronary syndrome, with or without ST-segment elevation (onset of symptoms within the previous 24h).
    Inclusion criteria acute coronary syndrome, with or without ST-segment elevation, with an onset of symptoms during the previous 24 hours;
    Exclusion criteria contraindication to clopidogrel; fibrinolytic therapy within 24 hours before; need for oral anticoagulation therapy; increased risk of bradycardia; concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
    Baseline characteristics
    Age (mean), years 62y (median) 
    female (%) 28.3% 
    BMI (mdian) 27 (13-70) 
    history of MI (%) 20.5% 
    Positive troponin I 85.7% 
    ST-elevation MI 37.8% 
    Non–ST-elevation MI 42.7% 

    Method and design

    Randomized effectives 9333 / 9291 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 1 y
    Number of centre 862
    Geographic area 43 countries
    Hypothesis Superiority
    Primary endpoint Cv death, MI, stroke


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    vascular death, MI, stroke 864 / 9333 (9,3%) 1014 / 9291 (10,9%) 0,85 [0,78;0,92]
    Death from any cause, MI, or stroke 901 / 9333 (9,7%) 1065 / 9291 (11,5%) 0,84 [0,77;0,92]
    vascular Death, MI, stroke, recurrent ischemia,TIA, other arterial thrombotic event 1290 / 9333 (13,8%) 1456 / 9291 (15,7%) 0,88 [0,82;0,95]
    MI 504 / 9333 (5,4%) 593 / 9291 (6,4%) 0,85 [0,75;0,95]
    Death from vascular causes 353 / 9333 (3,8%) 442 / 9291 (4,8%) 0,80 [0,69;0,91]
    Stroke 125 / 9333 (1,3%) 106 / 9291 (1,1%) 1,17 [0,91;1,52]
    Ischemic stroke 96 / 9333 (1,0%) 91 / 9291 (1,0%) 1,05 [0,79;1,40]
    Hemorrhagic stroke 23 / 9333 (0,2%) 13 / 9291 (0,1%) 1,76 [0,89;3,47]
    Unknown stroke 10 / 9333 (0,1%) 2 / 9291 (0,0%) 4,98 [1,09;22,71]
    Death from any cause 399 / 9333 (4,3%) 506 / 9291 (5,4%) 0,78 [0,69;0,89]
    Death from causes other than vascular causes 46 / 9333 (0,5%) 64 / 9291 (0,7%) 0,72 [0,49;1,04]
    Severe recurrent ischemia 302 / 9333 (3,2%) 345 / 9291 (3,7%) 0,87 [0,75;1,01]
    Recurrent ischemia 500 / 9333 (5,4%) 536 / 9291 (5,8%) 0,93 [0,82;1,05]
    TIA 18 / 9333 (0,2%) 23 / 9291 (0,2%) 0,78 [0,42;1,44]
    Other arterial thrombotic event 19 / 9333 (0,2%) 31 / 9291 (0,3%) 0,61 [0,34;1,08]
    Death from vascular causes, MI, stroke Invasive treatment planned 569 / 9333 (6,1%) 668 / 9291 (7,2%) 0,85 [0,76;0,94]
    Death from vascular causes, MI, stroke days 1–30 443 / 9333 (4,7%) 502 / 9291 (5,4%) 0,88 [0,78;0,99]
    Death from vascular causes, MI, stroke, days 31–360 413 / 9333 (4,4%) 510 / 9291 (5,5%) 0,81 [0,71;0,91]
    Definite Stent thrombosis 71 / 9333 (0,8%) 106 / 9291 (1,1%) 0,67 [0,49;0,90]
    Probable or definite Stent thrombosis 118 / 9333 (1,3%) 158 / 9291 (1,7%) 0,74 [0,59;0,94]
    Possible, probable, or definite Stent thrombosis 155 / 9333 (1,7%) 202 / 9291 (2,2%) 0,76 [0,62;0,94]
    Major bleeding study criteria 961 / 9333 (10,3%) 929 / 9291 (10,0%) 1,03 [0,95;1,12]
    TIMI Major bleeding 657 / 9333 (7,0%) 638 / 9291 (6,9%) 1,03 [0,92;1,14]
    Bleeding requiring red-cell transfusion 818 / 9333 (8,8%) 809 / 9291 (8,7%) 1,01 [0,92;1,10]
    Life-threatening or fatal bleeding 491 / 9333 (5,3%) 480 / 9291 (5,2%) 1,02 [0,90;1,15]
    Fatal bleeding 20 / 9333 (0,2%) 23 / 9291 (0,2%) 0,87 [0,48;1,58]
    Nonintracranial fatal bleeding 9 / 9333 (0,1%) 21 / 9291 (0,2%) 0,43 [0,20;0,93]
    Intracranial bleeding 26 / 9333 (0,3%) 14 / 9291 (0,2%) 1,85 [0,97;3,54]
    Fatal Intracranial bleeding 11 / 9333 (0,1%) 1 / 9291 (0,0%) 10,95 [1,41;84,80]
    Nonfatal Intracranial bleeding 15 / 9333 (0,2%) 13 / 9291 (0,1%) 1,15 [0,55;2,41]
    Non–CABG-related major bleeding 362 / 9333 (3,9%) 306 / 9291 (3,3%) 1,18 [1,01;1,37]
    TIMI Non–CABG-related major bleeding 221 / 9333 (2,4%) 177 / 9291 (1,9%) 1,24 [1,02;1,51]
    CABG-related major bleeding 619 / 9333 (6,6%) 654 / 9291 (7,0%) 0,94 [0,85;1,05]
    TIMI CABG-related major bleeding 446 / 9333 (4,8%) 476 / 9291 (5,1%) 0,93 [0,82;1,06]
    Major or minor bleeding 1339 / 9333 (14,3%) 1215 / 9291 (13,1%) 1,10 [1,02;1,18]
    TIMI Major or minor bleeding 946 / 9333 (10,1%) 906 / 9291 (9,8%) 1,04 [0,95;1,13]
    Any Dyspnea 1270 / 9333 (13,6%) 721 / 9291 (7,8%) 1,75 [1,61;1,91]
    Dyspnea Requiring discontinuation of study treatment 79 / 9333 (0,8%) 13 / 9291 (0,1%) 6,05 [3,37;10,87]

    Endpoints used by the meta-analysis and data retained for this trial

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

    Vascular death

    353 / 9333
         442 / 9291
         0,80 [0,69;0,91]

    Non vascular death

    46 / 9333
         64 / 9291
         0,72 [0,49;1,04]

    myocardial infarction (fatal and non fatal)

    504 / 9333
         593 / 9291
         0,85 [0,75;0,95]

    fatal bleeding

    20 / 9333
         23 / 9291
         0,87 [0,48;1,58]

    Bleeding

    946 / 9333
         906 / 9291
         1,04 [0,95;1,13]

    Vascular events

    1290 / 9333
         1456 / 9291
         0,88 [0,82;0,95]

    Major bleeding

    657 / 9333
         638 / 9291
         1,03 [0,92;1,14]

    stroke (fatal and non fatal)

    125 / 9333
         106 / 9291
         1,17 [0,91;1,52]

    All cause death

    399 / 9333
         506 / 9291
         0,78 [0,69;0,89]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Vascular death 353 / 9333 (3,8%) 442 / 9291 (4,8%) 0,80 [0,69;0,91]    
    Non vascular death 46 / 9333 (0,5%) 64 / 9291 (0,7%) 0,72 [0,49;1,04]    
    myocardial infarction (fatal and non fatal) 504 / 9333 (5,4%) 593 / 9291 (6,4%) 0,85 [0,75;0,95]    
    All cause death 399 / 9333 (4,3%) 506 / 9291 (5,4%) 0,78 [0,69;0,89]    
    Vascular events 1290 / 9333 (13,8%) 1456 / 9291 (15,7%) 0,88 [0,82;0,95]    
    Major bleeding 657 / 9333 (7,0%) 638 / 9291 (6,9%) 1,03 [0,92;1,14] TIMI criteria   
    stroke (fatal and non fatal) 125 / 9333 (1,3%) 106 / 9291 (1,1%) 1,17 [0,91;1,52]    
    fatal bleeding 20 / 9333 (0,2%) 23 / 9291 (0,2%) 0,87 [0,48;1,58]    
    Bleeding 946 / 9333 (10,1%) 906 / 9291 (9,8%) 1,04 [0,95;1,13] TIMI criteria   
    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
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Vascular death 3,78% 4,76% -9,8‰
    Non vascular death 4,93‰ 6,89‰ -2,0‰
    myocardial infarction (fatal and non fatal) 5,40% 6,38% -9,8‰
    All cause death 4,28% 5,45% -11,7‰
    Vascular events 13,82% 15,67% -18,5‰
    Major bleeding 7,04% 6,87% 1,7‰
    stroke (fatal and non fatal) 1,34% 1,14% 2,0‰
    fatal bleeding 2,14‰ 2,48‰ -0,3‰
    Bleeding 10,14% 9,75% 3,8‰


    Reference(s)

    Trials register # NCT00391872
    • James S, Akerblom A, Cannon CP, Emanuelsson H, Husted S, Katus H, Skene A, Steg PG, Storey RF, Harrington R, Becker R, Wallentin L. Comparison of ticagrelor, the first reversible oral P2Y(12) receptor antagonist, with clopidogrel in patients with acute coronary syndromes: Rationale, design, and baseline characteristics of the PLATelet inhibition and patient Outcomes (PLATO) trial.. Am Heart J 2009;157:599-605
      Pubmed | Hubmed | Fulltext
    • Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA. Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes.. N Engl J Med 2009 Aug 30;:
      Pubmed | Hubmed | Fulltext

    External links about this trial

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