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See also:

  • All acute coronary syndrome clinical trials
  • All clinical trials of heparin (UFH or LMWH)
  • All clinical trials of enoxaparin
    		•  

    TIMI 11 B (long term) study, 1998

    Treatments

    Studied treatment enoxaprin during both the acute phase (IV) and outpatient phase (SC)
    enoxaprin during both the acute phase (initial 30 mg intravenous bolus followed by injections of 1.0 mg/kg every 12 hours) and outpatient phase for an additional 35 days after hospital discharge (injections every 12 hours of 40 mg for patients weighing ,65 kg and 60 mg for those weighing >65 kg)
    Control treatment intravenous UFH for >=3 days (followed by subcutaneous placebo injections)
    Concomittant treatment All patients received aspirin (100 to 325 mg/d)

    Patients

    Patients unstable angina/non–Q-wave myocardial infarction

    Method and design

    Randomized effectives 1953 / 1957 (studied vs. control)
    Blinding double blind
    Follow-up duration 43 days
    Geographic area North America, South America,
    Hypothesis Superiority
    Primary endpoint death, MI or urgent revascularization
    Remarks

    Remarks / Comments



    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death at D43 75 / 1953 (3,8%) 78 / 1957 (4,0%) 0,96 [0,71;1,31]
    MI at D43 107 / 1953 (5,5%) 129 / 1957 (6,6%) 0,83 [0,65;1,07]
    Urgent revascularization at D43 208 / 1953 (10,7%) 247 / 1957 (12,6%) 0,84 [0,71;1,00]
    Death/MI at D43 155 / 1953 (7,9%) 174 / 1957 (8,9%) 0,89 [0,73;1,10]
    Death/MI/Urgent revascularization at D43 337 / 1953 (17,3%) 385 / 1957 (19,7%) 0,88 [0,77;1,00]

    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]

    Revascularization

    208 / 1953
         247 / 1957
         0,84 [0,71;1,00]

    Major bleeding

    34 / 1179
         18 / 1185
         classic 1,90 [1,08;3,34]

    Minor bleeding

    227 / 1179
         62 / 1185
         classic 3,68 [2,81;4,82]

    myocardial infarction or death

    155 / 1953
         174 / 1957
         0,89 [0,73;1,10]

    myocardial infarction (fatal and non fatal)

    107 / 1953
         129 / 1957
         0,83 [0,65;1,07]

    All cause death

    75 / 1953
         78 / 1957
         0,96 [0,71;1,31]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Revascularization 208 / 1953 (10,7%) 247 / 1957 (12,6%) 0,84 [0,71;1,00] urgent revascularization at D43  0 
    Major bleeding 34 / 1179 (2,9%) 18 / 1185 (1,5%) 1,90 [1,08;3,34] between D8 and D43  0 
    Minor bleeding 227 / 1179 (19,3%) 62 / 1185 (5,2%) 3,68 [2,81;4,82] between D8 and D43  0 
    myocardial infarction or death 155 / 1953 (7,9%) 174 / 1957 (8,9%) 0,89 [0,73;1,10] at D43  0 
    myocardial infarction (fatal and non fatal) 107 / 1953 (5,5%) 129 / 1957 (6,6%) 0,83 [0,65;1,07] at D43  0 
    All cause death 75 / 1953 (3,8%) 78 / 1957 (4,0%) 0,96 [0,71;1,31] at D43  0 
    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.
    Revascularization 10,65% 12,62% -19,7‰
    Major bleeding 2,88% 1,52% 1,4%
    Minor bleeding 19,25% 5,23% 14,0%
    myocardial infarction or death 7,94% 8,89% -9,5‰
    myocardial infarction (fatal and non fatal) 5,48% 6,59% -11,1‰
    All cause death 3,84% 3,99% -1,5‰


    Reference(s)

    Trials register # NA

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