Abstract | BACKGROUND: METHODS: We conducted a prospective, double-blind trial in which 7232 patients were randomly assigned to receive 20 mg of oral xemilofiban or placebo 30 to 90 minutes before undergoing percutaneous coronary revascularization, with maintenance doses of 10 or 20 mg of xemilofiban or placebo administered three times daily for up to 182 days. There were two primary composite end points: one was death, nonfatal myocardial infarction, or urgent revascularization at 182 days, and the other was death or nonfatal myocardial infarction at 182 days. RESULTS: Death, myocardial infarction, or urgent revascularization occurred within 182 days in 324 patients who received placebo (Kaplan-Meier cumulative event rate, 13.5 percent), 332 who received 10 mg of xemilofiban (13.9 percent, P=0.82 for the comparison with placebo), and 306 who received 20 mg of xemilofiban (12.7 percent, P=0.36 for the comparison with placebo). The incidence of death or myocardial infarction was also similar in all three groups. Clinically significant hemorrhagic complications and thrombocytopenia were infrequent. CONCLUSIONS:
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Authors | W W O'Neill, P Serruys, M Knudtson, G A van Es, G C Timmis, C van der Zwaan, J Kleiman, J Gong, E B Roecker, R Dreiling, J Alexander, R Anders |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 342
Issue 18
Pg. 1316-24
(May 04 2000)
ISSN: 0028-4793 [Print] United States |
PMID | 10793164
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzamidines
- Platelet Aggregation Inhibitors
- xemilofiban
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Topics |
- Administration, Oral
- Aged
- Angioplasty, Balloon, Coronary
(statistics & numerical data)
- Benzamidines
(administration & dosage, adverse effects)
- Coronary Artery Bypass
(statistics & numerical data)
- Coronary Disease
(mortality, therapy)
- Disease-Free Survival
- Double-Blind Method
- Drug Administration Schedule
- Female
- Hemorrhage
(chemically induced)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(prevention & control)
- Platelet Aggregation Inhibitors
(administration & dosage, adverse effects)
- Recurrence
- Stents
- Thrombocytopenia
(chemically induced)
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