The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention

Summary

* The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg) clopidogrel. * About 44 people will be in the study. The study duration is a single hospitalization period during which the angioplasty will be performed in addition to a 30-day post hospitalization follow-up period. * Patients taking part in the study will be assigned by chance into two groups. * Group 1: patients will be treated with the glycoprotein inhibitor, Tirofiban (25mcg/kg over 3 min bolus dose and 0.15 mcg/kg/hr for 12-24 hours), started immediately after insertion of the sheath. * Group 2: patients will be treated with equivalent placebo All patients will be loaded with 600 mg clopidogrel at least 4 hours prior to scheduled intervention. All patients will have platelet function analyses at baseline and following treatment.

Timeline

Start

2007-11

Primary completion

—

Completion

2008-12

Publications

• Background Danzi GB, Capuano C, Sesana M, Baglini R. Preliminary experience with a high bolus dose of tirofiban during percutaneous coronary intervention. Curr Med Res Opin. 2003;19(1):28-33. doi: 10.1185/030079902125001380.
• Background Schneider DJ, Herrmann HC, Lakkis N, Aguirre F, Wan Y, Aggarwal A, Kabbani SS, DiBattiste PM. Enhanced early inhibition of platelet aggregation with an increased bolus of tirofiban. Am J Cardiol. 2002 Dec 15;90(12):1421-3. doi: 10.1016/s0002-9149(02)02892-8. No abstract available.
• Background Valgimigli M, Percoco G, Barbieri D, Ferrari F, Guardigli G, Parrinello G, Soukhomovskaia O, Ferrari R. The additive value of tirofiban administered with the high-dose bolus in the prevention of ischemic complications during high-risk coronary angioplasty: the ADVANCE Trial. J Am Coll Cardiol. 2004 Jul 7;44(1):14-9. doi: 10.1016/j.jacc.2004.03.042.
• Background Kimmelstiel C, Badar J, Covic L, Waxman S, Weintraub A, Jacques S, Kuliopulos A. Pharmacodynamics and pharmacokinetics of the platelet GPIIb/IIIa inhibitor tirofiban in patients undergoing percutaneous coronary intervention: implications for adjustment of tirofiban and clopidogrel dosage. Thromb Res. 2005;116(1):55-66. doi: 10.1016/j.thromres.2004.11.011. Epub 2004 Dec 8.
• Background Bonz AW, Lengenfelder B, Strotmann J, Held S, Turschner O, Harre K, Wacker C, Waller C, Kochsiek N, Meesmann M, Neyses L, Schanzenbacher P, Ertl G, Voelker W. Effect of additional temporary glycoprotein IIb/IIIa receptor inhibition on troponin release in elective percutaneous coronary interventions after pretreatment with aspirin and clopidogrel (TOPSTAR trial). J Am Coll Cardiol. 2002 Aug 21;40(4):662-8. doi: 10.1016/s0735-1097(02)02014-4.
• Background Wheeler GL, Braden GA, Steinhubl SR, Kereiakes DJ, Kottke-Marchant K, Michelson AD, Furman MI, Mueller MN, Moliterno DJ, Sane DC. The Ultegra rapid platelet-function assay: comparison to standard platelet function assays in patients undergoing percutaneous coronary intervention with abciximab therapy. Am Heart J. 2002 Apr;143(4):602-11. doi: 10.1067/mhj.2002.121734.
• Background Gurbel PA, Bliden KP, Zaman KA, Yoho JA, Hayes KM, Tantry US. Clopidogrel loading with eptifibatide to arrest the reactivity of platelets: results of the Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS) study. Circulation. 2005 Mar 8;111(9):1153-9. doi: 10.1161/01.CIR.0000157138.02645.11. Epub 2005 Feb 28.

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