(Circulation. 2000;102:624.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Double-Blind Study of the Safety of Clopidogrel With and Without a Loading Dose in Combination With Aspirin Compared With Ticlopidine in Combination With Aspirin After Coronary Stenting
The Clopidogrel Aspirin Stent International Cooperative Study (CLASSICS)
From the Department of Cardiology, Hôpital Cardiologique, Lille, France (M.E.B.); Klinikum der Johannes-Gutenberg-Universität, Mainz, Germany (H.-J.R.); Division of Cardiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (P.U.); and Department of Cardiology, Glenfield General Hospital, Leicester, UK (A.H.G.).
Correspondence to Michel E. Bertrand, MD, Department of Cardiology B, Hôpital Cardiologique, 59037 Lille, France. E-mail mbcardio{at}ccub.internet.fr
Background—Combination therapy with the ADP receptor antagonist ticlopidine plus aspirin has emerged as standard care after coronary stenting. Clopidogrel, a new ADP receptor antagonist, has greater molar potency than ticlopidine and better safety/tolerability.
Methods and Results—Patients (n=1020) were randomized after successful stent placement and initiated on a 28-day regimen of either (1) 300-mg clopidogrel loading dose and 325 mg/d aspirin on day 1, followed by 75 mg/d clopidogrel and 325 mg/d aspirin; (2) 75 mg/d clopidogrel and 325 mg/d aspirin; or (3) 250 mg BID ticlopidine and 325 mg/d aspirin. The primary end point consisted of major peripheral or bleeding complications, neutropenia, thrombocytopenia, or early discontinuation of study drug as the result of a noncardiac adverse event during the study-drug treatment period. The primary end point occurred in 9.1% of patients (n=31) in the ticlopidine group and 4.6% of patients (n=31) in the combined clopidogrel group (relative risk 0.50; 95% CI 0.31 to 0.81; P=0.005). Overall rates of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization) were low and comparable between treatment groups (0.9% with ticlopidine, 1.5% with 75 mg/d clopidogrel, 1.2% with the clopidogrel loading dose; P=NS for all comparisons).
Conclusions—The safety/tolerability of clopidogrel (plus aspirin) is superior to that of ticlopidine (plus aspirin) (P=0.005). The 300-mg loading dose was well tolerated, notably with no increased risk of bleeding. Secondary end point data are consistent with the hypothesis that clopidogrel and ticlopidine have comparable efficacy with regard to cardiac events after successful stenting.
Key Words: aspirin • receptors • stents • thrombosis • ticlopidine
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H. S. Markus, D. W. Droste, M. Kaps, V. Larrue, K. R. Lees, M. Siebler, and E. B. Ringelstein Dual Antiplatelet Therapy With Clopidogrel and Aspirin in Symptomatic Carotid Stenosis Evaluated Using Doppler Embolic Signal Detection: The Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) Trial Circulation, May 3, 2005; 111(17): 2233 - 2240. [Abstract] [Full Text] [PDF]
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H Suryapranata, G De Luca, A W J van 't Hof, J P Ottervanger, J C A Hoorntje, J-H E Dambrink, A T M Gosselink, F Zijlstra, and M-J de Boer Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients Heart, May 1, 2005; 91(5): 641 - 645. [Abstract] [Full Text] [PDF]
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P. M.W. Bath, L. Zhao, and S. Heptinstall Current status of stroke prevention in patients with atrial fibrillation Eur. Heart J. Suppl., May 1, 2005; 7(suppl_C): C12 - C18. [Abstract] [Full Text] [PDF]
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G. Patti, G. Colonna, V. Pasceri, L. L. Pepe, A. Montinaro, and G. Di Sciascio Randomized Trial of High Loading Dose of Clopidogrel for Reduction of Periprocedural Myocardial Infarction in Patients Undergoing Coronary Intervention: Results From the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) Study Circulation, April 26, 2005; 111(16): 2099 - 2106. [Abstract] [Full Text] [PDF]
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Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]
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R. Ascione, A. Ghosh, C. A. Rogers, A. Cohen, C. Monk, and G. D. Angelini In-Hospital Patients Exposed to Clopidogrel Before Coronary Artery Bypass Graft Surgery: A Word of Caution Ann. Thorac. Surg., April 1, 2005; 79(4): 1210 - 1216. [Abstract] [Full Text] [PDF]
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M. J. Claeys, M. G. Van der Planken, J. M. Bosmans, J. J. Michiels, F. Vertessen, P. Van Der Goten, F. L. Wuyts, and C. J. Vrints Does pre-treatment with aspirin and loading dose clopidogrel obviate the need for glycoprotein IIb/IIIa antagonists during elective coronary stenting? A focus on peri-procedural myonecrosis Eur. Heart J., March 2, 2005; 26(6): 567 - 575. [Abstract] [Full Text] [PDF]
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M-A von Mach, A Eich, L S Weilemann, and T Munzel Subacute coronary stent thrombosis in a patient developing clopidogrel associated thrombotic thrombocytopenic purpura Heart, February 1, 2005; 91(2): e14 - e14. [Abstract] [Full Text] [PDF]
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D. E. Kandzari, P. B. Berger, A. Kastrati, S. R. Steinhubl, J. Mehilli, F. Dotzer, J. M. ten Berg, F.-J. Neumann, H. Bollwein, J. Dirschinger, et al. Influence of treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization J. Am. Coll. Cardiol., December 7, 2004; 44(11): 2133 - 2136. [Abstract] [Full Text] [PDF]
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L. Chen, A. W. Bracey, R. Radovancevic, J. R. Cooper Jr, C. D. Collard, W. K. Vaughn, and N. A. Nussmeier Clopidogrel and bleeding in patients undergoing elective coronary artery bypass grafting J. Thorac. Cardiovasc. Surg., September 1, 2004; 128(3): 425 - 431. [Abstract] [Full Text] [PDF]
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C. Patrono, B. Coller, G. A. FitzGerald, J. Hirsh, and G. Roth Platelet-Active Drugs: The Relationships Among Dose, Effectiveness, and Side Effects: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy Chest, September 1, 2004; 126(3_suppl): 234S - 264S. [Abstract] [Full Text] [PDF]
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J. J. Popma, P. Berger, E. M. Ohman, R. A. Harrington, C. Grines, and J. I. Weitz Antithrombotic Therapy During Percutaneous Coronary Intervention: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy Chest, September 1, 2004; 126(3_suppl): 576S - 599S. [Abstract] [Full Text] [PDF]
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Writing Committee Members, E. M. Antman, D. T. Anbe, P. W. Armstrong, E. R. Bates, L. A. Green, M. Hand, J. S. Hochman, H. M. Krumholz, F. G. Kushner, et al. ACC/AHA guidelines for the management of patients with ST-Elevation myocardial infarction--executive summary: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (writing committee to revise the 1999 guidelines for the management of patients with acute myocardial infarction) J. Am. Coll. Cardiol., August 4, 2004; 44(3): 671 - 719. [Full Text] [PDF]
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E. M. Antman, D. T. Anbe, P. W. Armstrong, E. R. Bates, L. A. Green, M. Hand, J. S. Hochman, H. M. Krumholz, F. G. Kushner, G. A. Lamas, et al. ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction--Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction) Circulation, August 3, 2004; 110(5): 588 - 636. [Full Text] [PDF]
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D. J. van der Heijden, I. C. D. Westendorp, R. K. Riezebos, F. Kiemeneij, T. Slagboom, L. R. van der Wieken, and G.-J. Laarman Lack of efficacy of clopidogrel pre-treatment in the prevention of myocardial damage after elective stent implantation J. Am. Coll. Cardiol., July 7, 2004; 44(1): 20 - 24. [Abstract] [Full Text] [PDF]
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M. L. Stadius Diminishing returns ...and too many choices ...the saga of pharmacologic therapy to reduce the complications of percutaneous coronary intervention J. Am. Coll. Cardiol., July 7, 2004; 44(1): 25 - 27. [Full Text] [PDF]
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G Montalescot, H R Andersen, D Antoniucci, A Betriu, M J de Boer, L Grip, F J Neumann, and M T Rothman Recommendations on percutaneous coronary intervention for the reperfusion of acute ST elevation myocardial infarction Heart, June 1, 2004; 90(6): e37 - e37. [Abstract] [Full Text] [PDF]
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D. A. Payne, C. I. Jones, P. D. Hayes, M. M. Thompson, N. J. London, P. R. Bell, A. H. Goodall, and A. R. Naylor Beneficial Effects of Clopidogrel Combined With Aspirin in Reducing Cerebral Emboli in Patients Undergoing Carotid Endarterectomy Circulation, March 30, 2004; 109(12): 1476 - 1481. [Abstract] [Full Text] [PDF]
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A. Lepantalo, K. S Virtanen, J. Heikkila, U. Wartiovaara, and R. Lassila Limited early antiplatelet effect of 300 mg clopidogrel in patients with aspirin therapy undergoing percutaneous coronary interventions Eur. Heart J., March 2, 2004; 25(6): 476 - 483. [Abstract] [Full Text] [PDF]
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S K Khambekar, J Kovac, and A H Gershlick Clopidogrel induced urticarial rash in a patient with left main stem percutaneous coronary intervention: management issues Heart, March 1, 2004; 90(3): e14 - 14. [Abstract] [Full Text] [PDF]
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 M W H Behan and R F Storey Antiplatelet therapy in cardiovascular disease Postgrad. Med. J., March 1, 2004; 80(941): 155 - 164. [Abstract] [Full Text] [PDF]
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