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ACUTE II
Antithrombotic Combination Using Tirofiban and Enoxaparin II
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Author(s) |
Cohen M, Théroux P, Borzak S, Frey MJ, White HD, Van Mieghem W, Senatore F, Lis J, Mukherjee R, Harris K, Bigonzi F
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Title(s) |
Randomized double-blind safety study of enoxaparin versus unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes treated with tirofiban and aspirin: The ACUTE II study
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Reference(s) |
Am Heart J 2002;144:470-7 |
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Disease |
Unstable angina pectoris/non-ST-segment elevation MI (UA/NSTEMI)
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Purpose |
To evaluate the safety of the low-molecular-weight heparin enoxaparin relative to unfractionated heparin (UFH) in patients treated with ASA and tirofiban by providing an estimate of bleeding incidences within the two groups
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Study design |
Randomised, double-blind, double-dummy, parallel-group
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Follow-up |
24 h
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Patients |
525 (210 UFH, 315 enoxaparin) with previous UA/NSTEMI and high risk of ischaemic events
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Treatment regimen |
UFH, 5000 U iv bolus, then 1000 U/h adjusted to an activated partial thromboplastin time of 1.5-2 times control, or enoxaparin, 1.0 mg/kg sc every 12 h
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Concomitant therapy |
All patients also received ASA, 160-325 mg/day, and tirofiban, 0.4 g/kg/min over 30 min then 0.1 g/kg/min
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Results |
The incidence of total TIMI bleeding events was 4.8% in the UFH group and 3.5% in the enoxaparin group. Blood transfusions were received by 4.3% receiving UFH and 2.5% receiving enoxaparin. The incidence of any bleeding event was 34.3% in the UFH group and 54.6% in the enoxaparin group; most of these were cutaneous (11.4% vs 30.8%; p ≤ 0.02)
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