Trial-Results center  
Clinical trial results database Feedback    Home


Related trials

ZEST AMI (vs SES), 2009 - zotarolimus ES vs sirolimus ES

TRIANA, 2009 - primary ballon angioplasty vs tenecteplase

NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis

Juwana, 2009 - sirolimus ES vs paclitaxel ES

ZEST AMI (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

PASEO, 2009 - drug ES vs bare-metal stent

CARESS, 2008 - thrombolysis + angioplasty vs immediate thrombolysis

HORIZONS-AMI Stent, 2008 - paclitaxel ES vs bare-metal stent

MISSION, 2008 - sirolimus ES vs bare-metal stent

DEDICATION, 2008 - drug ES vs bare-metal stent

Díaz de la Llera, 2007 - sirolimus ES vs bare-metal stent

SESAMI, 2007 - sirolimus ES vs bare-metal stent

TYPHOON, 2006 - sirolimus ES vs bare-metal stent

PROSIT, 2006 - sirolimus ES vs paclitaxel ES

HAAMU-STENT, 2006 - paclitaxel ES vs bare-metal stent

PASSION, 2006 - paclitaxel ES vs bare-metal stent

WEST, 2006 - systematic PCI (+stent) vs no systematic PCI

CAPITAL AMI, 2005 - thrombolysis + angioplasty vs immediate thrombolysis

Di Lorenzo et al., 2005 - sirolimus ES vs paclitaxel ES

ZWOLLE 6, 2005 - primary stenting vs ballon angioplasty

CAPITAL AMI, 2005 - systematic PCI (+stent) vs no systematic PCI

senior PAMI, 2005 - primary PCI vs thrombolytic therapy

STOPAMI 3, 2004 - primary stenting vs ballon angioplasty

GRACIA-1, 2004 - systematic PCI (+stent) vs no systematic PCI

MERLIN (Sutton), 2004 - immediate systematic ballon angioplastyte vs no immediate angioplasty



See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of bolus t-PA
    		•  

    COBALT study, 1997

    Treatments

    Studied treatment of 50 mg of alteplase over a period of 1 to 3 minutes followed 30 minutes later by a second bolus of 50 mg (or 40 mg for patients who weighed less than 60 kg).
    Control treatment weight-adjusted, accelerated infusion of 100 mg of alteplase
    Concomittant treatment Aspirine le plus tôt possible (160-325 mg), puis 80 à 325 mg/j; héparine en IV, bolus de 5000 U, puis 1000 U/h pendant au moins 48 h (cible temps de thromboplastine: 60 à 80 s)

    Patients

    Patients patients with acute myocardial infarction
    Inclusion criteria Douleur thoracique ischémique > ou = 20 min ; symptômes < 6 h; sus-décalage ST > ou = 0.1 mV dans > ou = 2 dérivations standards ou sus-décalage ST > ou = 0.2 mV dans > ou = 2 dérivations précordiales ou les 2
    Exclusion criteria Hémorragies; antécédent AVC ou atteinte structurale du système nerveux central; ponction vasculaire non compressible récente; chirurgie majeure ou traumatisme < 6 mois; participation antérieure à la même étude; grossesse, allaitement ou accouchement < 30 j; PAS > ou = 180 mmHg, PAD > ou = 110 mmHg ou les 2 malgré traitement

    Method and design

    Randomized effectives 3585 / 3584 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 30 days
    Lost to follow-up ND
    Hypothesis non inferiority
    Primary endpoint death 30d
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    286 / 3585
         270 / 3584
         1,06 [0,90;1,24]

    stroke (fatal and non fatal)

    69 / 3585
         55 / 3584
         1,25 [0,88;1,78]

    Major bleeding

    24 / 3585
         22 / 3584
         1,09 [0,61;1,94]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    short term death 286 / 3585 (8,0%) 270 / 3584 (7,5%) 1,06 [0,90;1,24]    
    stroke (fatal and non fatal) 69 / 3585 (1,9%) 55 / 3584 (1,5%) 1,25 [0,88;1,78]    
    Major bleeding 24 / 3585 (0,7%) 22 / 3584 (0,6%) 1,09 [0,61;1,94]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    short term death 7,98% 7,53% 4,4‰
    stroke (fatal and non fatal) 1,92% 1,53% 3,9‰
    Major bleeding 6,69‰ 6,14‰ 0,6‰


    Reference(s)

    Trials register # NA
    • . A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. The Continuous Infusion versus Double-Bolus Administration of Alteplase (COBALT) Investigators.. N Engl J Med 1997 Oct 16;337:1124-30
      Pubmed | Hubmed | Fulltext

    (c) 2004-2010 TrialResults-center - All Rights Reserved

    Tweet this  |  notify a friend