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See also:

  • All percutaneous coronary intervention clinical trials
  • All acute coronary syndrome clinical trials
  • All clinical trials of pre treatment for PCI
  • All clinical trials of cangrelor up front
  •  

    CHAMPION-PCI study, 2009

    [NCT00305162] download pdf: cangrelor up front | antithrombotics for percutaneous coronary intervention

    Treatments

    Studied treatment cangrelor up front (cangrelor administered before percutaneous coronary intervention and followed by clopidogrel)
    cangrelor (intravenous bolus of 30 ìg/kg followed by intravenous infusion of 4 µg/kg/min) began within 30 minutes before PCI and continued for at least 2 hours or until the conclusion of the index procedure. 600 mg of clopidogrel at the time of infusion and at discontinuation of infusion
    Control treatment clopidogrel up front (clopidogrel followed by placebo)
    placebo at the discontinuation of the study-drug infusion (before oral clopidogrel)
    Concomittant treatment 75 to 325 mg of aspirin according to local-site standards
    Remarks cangrelor then clopidogrel vs clopidogrel then placebo

    Patients

    Patients high risk patients requiring PCI
    Inclusion criteria stable angina, unstable angina, or non–ST-segment–elevation myocardial infarction with obstructive coronary artery disease and scheduled for PCI, ST-segment–elevation myocardial infarction with primary PCI

    Method and design

    Randomized effectives 4367 / 4355 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 48 h
    Lost to follow-up 0.7% (at 48h)
    Number of centre 268
    Geographic area 14 countries
    Hypothesis Superiority
    Primary endpoint death, MI, ischemia-driven revascularization


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Primary end point: death, myocardial infarction, or ischemia-driven revascularization 290 / 3889 (7,5%) 276 / 3865 (7,1%) 1,04 [0,89;1,22]
    Myocardial infarction 278 / 3889 (7,1%) 256 / 3865 (6,6%) 1,08 [0,92;1,27]
    Ischemia-driven revascularization 13 / 3889 (0,3%) 23 / 3865 (0,6%) 0,56 [0,28;1,11]
    Death from any cause 8 / 3889 (0,2%) 5 / 3865 (0,1%) 1,59 [0,52;4,86]
    Stent thrombosis 7 / 3889 (0,2%) 11 / 3865 (0,3%) 0,63 [0,25;1,63]
    Stroke 6 / 3889 (0,2%) 7 / 3865 (0,2%) 0,85 [0,29;2,53]
    Q-wave myocardial infarction 4 / 3889 (0,1%) 10 / 3865 (0,3%) 0,40 [0,12;1,27]
    Death, Q-wave myocardial infarction, or ischemia-driven revas-cularization 23 / 3889 (0,6%) 34 / 3865 (0,9%) 0,67 [0,40;1,14]
    Death, Q-wave myocardial infarction, or stent thrombosis 18 / 3889 (0,5%) 23 / 3865 (0,6%) 0,78 [0,42;1,44]

    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]

    stroke (fatal and non fatal)

    6 / 3889
    7 / 3865
    classic 0,85 [0,29;2,53]

    All cause death

    8 / 3889
    5 / 3865
    classic 1,59 [0,52;4,86]

    MI (fatal and non fatal)

    4 / 3889
    10 / 3865
    0,40 [0,12;1,27]

    MACE

    23 / 3889
    34 / 3865
    0,67 [0,40;1,14]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    MI (fatal and non fatal) 4 / 3889 (0,1%) 10 / 3865 (0,3%) 0,40 [0,12;1,27] Q-wave myocardial infarction
    MACE 23 / 3889 (0,6%) 34 / 3865 (0,9%) 0,67 [0,40;1,14] Death, Q-wave myocardial infarction, or ischemia-driven revas-cularization
    stroke (fatal and non fatal) 6 / 3889 (0,2%) 7 / 3865 (0,2%) 0,85 [0,29;2,53] Stroke
    All cause death 8 / 3889 (0,2%) 5 / 3865 (0,1%) 1,59 [0,52;4,86] Death from any cause
    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.
    MI (fatal and non fatal) 1,03‰ 2,59‰ -1,6‰
    MACE 5,91‰ 8,80‰ -2,9‰
    stroke (fatal and non fatal) 1,54‰ 1,81‰ -0,3‰
    All cause death 2,06‰ 1,29‰ 0,8‰

    Meta-analysis of all similar trials:

    antithrombotics in percutaneous coronary intervention for all type of patients

    New P2Y12 Inhibitors in acute coronary syndrome for all type of patients

    pre treatment for PCI in percutaneous coronary intervention for stable and unstable ACS



    Reference(s)

    Trials register # NCT00305162
    • Harrington RA, Stone GW, McNulty S, White HD, Lincoff AM, Gibson CM, Pollack CV Jr, Montalescot G, Mahaffey KW, Kleiman NS, Goodman SG, Amine M, Angiolillo DJ, Becker RC, Chew DP, French WJ, Leisch F, Parikh KH, Skerjanec S, Bhatt DL. Platelet inhibition with cangrelor in patients undergoing PCI.. N Engl J Med 2009 Dec 10;361:2318-29
      Pubmed | Hubmed | Fulltext

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