Clinical Investigations: Acute Ischemic Heart DiseaseRandomized 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☆,☆☆,★
Section snippets
Subjects
A total of 525 patients who were at higher risk for ischemic events and had UA/NSTEMI were enrolled. The entry criteria included prolonged (≥20 minutes) or repetitive episodes of angina at rest or with minimal effort within the previous 24 hours and either evidence by means of electrocardiogram (ECG) of myocardial ischemia or abnormal cardiac markers. Electrocardiographic changes included new ST-segment depression, transient elevation ≥1 mm, or T-wave inversions (in ≥3 leads). Abnormal cardiac
Study population
Five hundred twenty-five patients were enrolled at 54 participating study sites (see Appendix); 210 patients were randomized to receive UFH, and 315 patients were randomized to receive enoxaparin. The baseline patient demographic and clinical characteristics are shown in Table I.Empty Cell Tirofiban + UFH (n = 210) Tirofiban + enoxaparin (n = 315) Age (y) Mean ± SD 63.7 ± 12.9 64.6 ± 11.7 Range 33-94 34-92 Sex (%) Male 141 (67.1) 207 (65.7)
Discussion
In this prospective, randomized study involving 525 patients, we found that coadministration of tirofiban and enoxaparin was well tolerated, with very few significant bleeding events, as classified by means of the TIMI criteria, relative to tirofiban and UFH. These observations are consistent with the results of a 55-patient pilot study,11 which showed that plasma clearance of tirofiban and the bleeding time were comparable whether coadministered with enoxaparin or UFH. This pilot study,
Acknowledgements
We thank Annemarie Thornton and Denise Manas, medical program coordinators from Merck, for the time and effort provided for this initiative and all the investigators and the worldwide Merck medical monitors and staff from clinical research operations.
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Supported by Merck Research Laboratories, West Point, Pa.
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Reprint requests: Marc Cohen, MD, Cardiac Cath Lab MS-119, Hahnemann University Hospital, Broad and Vine Streets, Philadelphia, PA 19102-1192.
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E-mail: [email protected]