메뉴 건너뛰기




Volumn 32, Issue 9, 2010, Pages 1664-1673

Comparison of effects of two different formulations of clopidogrel bisulfate tablets on platelet aggregation and bleeding time in healthy Korean volunteers: A single-dose, randomized, open-label, 1-week, two-period, phase IV crossover study

Author keywords

Antiplatelet; Clopidogrel; Effect; Safety

Indexed keywords

CLOPIDOGREL;

EID: 77958187538     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.08.001     Document Type: Article
Times cited : (13)

References (28)
  • 1
    • 0033866132 scopus 로고    scopus 로고
    • Clopidogrel: A review of its use in the prevention of atherothrombosis
    • [published correction appears in Drug. 2001;61:52]
    • Jarvis B, Simpson K Clopidogrel: A review of its use in the prevention of atherothrombosis. Drugs. 2000, 60:347-377. [published correction appears in Drug. 2001;61:52].
    • (2000) Drugs. , vol.60 , pp. 347-377
    • Jarvis, B.1    Simpson, K.2
  • 2
    • 0030590746 scopus 로고    scopus 로고
    • A randomised, blinded, trial of Clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE)
    • CAPRIE Steering Committee
    • A randomised, blinded, trial of Clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996, 348:1329-1339. CAPRIE Steering Committee.
    • (1996) Lancet. , vol.348 , pp. 1329-1339
  • 5
    • 0033003725 scopus 로고    scopus 로고
    • Biochemical and pharmacological properties of Clopidogrel: A new ADP receptor antagonist
    • Herbert J-M, Savi P, Maffrand J-P Biochemical and pharmacological properties of Clopidogrel: A new ADP receptor antagonist. Eur Heart J Suppls. 1999, 1:A31-A40.
    • (1999) Eur Heart J Suppls. , vol.1
    • Herbert, J.-M.1    Savi, P.2    Maffrand, J.-P.3
  • 6
    • 0026559668 scopus 로고
    • Clopidogrel inhibits the binding of ADP analogues to the receptor mediating inhibition of platelet adenylate cyclase
    • Mills DC, Puri R, Hu CJ, et al. Clopidogrel inhibits the binding of ADP analogues to the receptor mediating inhibition of platelet adenylate cyclase. Arterioscler Thromb. 1992, 12:430-436.
    • (1992) Arterioscler Thromb. , vol.12 , pp. 430-436
    • Mills, D.C.1    Puri, R.2    Hu, C.J.3
  • 7
    • 0003132992 scopus 로고    scopus 로고
    • Clopidogrel: An antithrombotic drug acting on the ADP-dependent activation pathway of human platelets
    • Savi P, Heilmann E, Nurden P, et al. Clopidogrel: An antithrombotic drug acting on the ADP-dependent activation pathway of human platelets. Clin Appl Thromb Hemost. 1996, 2:35-42.
    • (1996) Clin Appl Thromb Hemost. , vol.2 , pp. 35-42
    • Savi, P.1    Heilmann, E.2    Nurden, P.3
  • 8
    • 18644372477 scopus 로고    scopus 로고
    • Structure and stereochemistry of the active metabolite of Clopidogrel
    • Pereillo JM, Maftouh M, Andrieu A, et al. Structure and stereochemistry of the active metabolite of Clopidogrel. DrugMetab Dispos. 2002, 30:1288-1295.
    • (2002) DrugMetab Dispos. , vol.30 , pp. 1288-1295
    • Pereillo, J.M.1    Maftouh, M.2    Andrieu, A.3
  • 9
    • 77952121828 scopus 로고    scopus 로고
    • Implications of inter-individual differences in Clopidogrel metabolism, with focus on pharmacogenetics
    • Accessed June 30, 2010.
    • Dahl ML, Gunes A Implications of inter-individual differences in Clopidogrel metabolism, with focus on pharmacogenetics. Pharmaceuticals. 2010, 3:782-794. Accessed June 30, 2010. http://www.mdpi.eom/1424-8247/3/4/782/pdf.
    • (2010) Pharmaceuticals. , vol.3 , pp. 782-794
    • Dahl, M.L.1    Gunes, A.2
  • 10
    • 0021267094 scopus 로고
    • Reference values for body fat content as a measure for desirable body fat content
    • Krämer HJ, Ulmer HV Reference values for body fat content as a measure for desirable body fat content. Z Ernah-rungswiss. 1984, 23:1-11.
    • (1984) Z Ernah-rungswiss. , vol.23 , pp. 1-11
    • Krämer, H.J.1    Ulmer, H.V.2
  • 11
    • 33749171078 scopus 로고    scopus 로고
    • Possible mechanisms of drug-induced aspirin and Clopidogrel resistance
    • Schroeder WS, Ghobrial L, Gandhi PJ Possible mechanisms of drug-induced aspirin and Clopidogrel resistance. J Thromb Thrombolysis. 2006, 22:139-150.
    • (2006) J Thromb Thrombolysis. , vol.22 , pp. 139-150
    • Schroeder, W.S.1    Ghobrial, L.2    Gandhi, P.J.3
  • 13
    • 0024259795 scopus 로고
    • Guidelines on platelet function testing
    • The British Society for Haematology BCSH Haemostasis and Thrombosis Task Force
    • Guidelines on platelet function testing. J Clin Pathol. 1988, 41:1322-1330. The British Society for Haematology BCSH Haemostasis and Thrombosis Task Force.
    • (1988) J Clin Pathol. , vol.41 , pp. 1322-1330
  • 14
    • 0035720060 scopus 로고    scopus 로고
    • Guideline for Good Clinical Practice
    • ICH Harmonised Tripartite Guideline
    • Guideline for Good Clinical Practice. J Postgrad Med. 2001, 47:199-203. ICH Harmonised Tripartite Guideline.
    • (2001) J Postgrad Med. , vol.47 , pp. 199-203
  • 15
    • 0018640322 scopus 로고
    • Controversy in counting and attributing events in clinical trials
    • Sackett DL, Gent M Controversy in counting and attributing events in clinical trials. N Engl J Med. 1979, 301:1410-1412.
    • (1979) N Engl J Med. , vol.301 , pp. 1410-1412
    • Sackett, D.L.1    Gent, M.2
  • 16
    • 0025949416 scopus 로고
    • The application of the principle of intention-to-treat to the analysis of clinical trials
    • Gillings D, Koch G The application of the principle of intention-to-treat to the analysis of clinical trials. Drug Inf J. 1991, 25:411-424.
    • (1991) Drug Inf J. , vol.25 , pp. 411-424
    • Gillings, D.1    Koch, G.2
  • 17
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DJ A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987, 15:657-680.
    • (1987) J Pharmacokinet Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 18
    • 0026361389 scopus 로고
    • European Community, Investigation of Bioavailability and Bioequivalence, (addendum 2). Accessed July 25, 2010.
    • The Rules Governing Medicinal Products in European Community 1991, 3:149-169. European Community, Investigation of Bioavailability and Bioequivalence, (addendum 2). Accessed July 25, 2010. http://www.clindesc.com/Guidelines_online/3%20Clinical/3.1%20General/3_1_2.pdf.
    • (1991) The Rules Governing Medicinal Products in European Community , vol.3 , pp. 149-169
  • 19
    • 0000533217 scopus 로고    scopus 로고
    • Benefit of Clopidogrel in patients with symptomatic cerebrovascular disease
    • Easton JD Benefit of Clopidogrel in patients with symptomatic cerebrovascular disease. Neurology. 1998, 50(Suppl 4):A157.
    • (1998) Neurology. , vol.50 , Issue.SUPPL. 4
    • Easton, J.D.1
  • 20
    • 0001339721 scopus 로고    scopus 로고
    • Marked superiority of Clopidogrel versus aspirin in patients with a history of previous cardiac surgery
    • Bhatt DL, Hirsch AT, Chew DP, et al. Marked superiority of Clopidogrel versus aspirin in patients with a history of previous cardiac surgery. J Am Coll Cardiol. 2000, 35(Suppl A):383.
    • (2000) J Am Coll Cardiol. , vol.35 , Issue.SUPPL. A , pp. 383
    • Bhatt, D.L.1    Hirsch, A.T.2    Chew, D.P.3
  • 21
    • 0000097359 scopus 로고    scopus 로고
    • Superiority of Clopidogrel versus aspirin in patients with a history of diabetes mellitus
    • Bhatt DL, Marso SP, Hiersch AT, et al. Superiority of Clopidogrel versus aspirin in patients with a history of diabetes mellitus. J Am Coll Cardiol. 2000, 35:409-410.
    • (2000) J Am Coll Cardiol. , vol.35 , pp. 409-410
    • Bhatt, D.L.1    Marso, S.P.2    Hiersch, A.T.3
  • 22
    • 0032806356 scopus 로고    scopus 로고
    • Generalizing the results of clinical trials to actual practice: The example of Clopidogrel therapy for the prevention of vascular events. CAPRA (CAPRIE Actual Practice Rates Analysis) Study Group. Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events
    • Caro JJ, Migliaccio-Walle K Generalizing the results of clinical trials to actual practice: The example of Clopidogrel therapy for the prevention of vascular events. CAPRA (CAPRIE Actual Practice Rates Analysis) Study Group. Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events. Am J Med. 1999, 107:568-572.
    • (1999) Am J Med. , vol.107 , pp. 568-572
    • Caro, J.J.1    Migliaccio-Walle, K.2
  • 23
    • 0343750695 scopus 로고    scopus 로고
    • A randomized comparison of Clopidogrel and aspirin versus ticlopidine and aspirin after the placement of coronary-artery stents
    • Müller C, Büttner HJ, Petersen J, Roskamm H A randomized comparison of Clopidogrel and aspirin versus ticlopidine and aspirin after the placement of coronary-artery stents. Circulation. 2000, 101:590-593.
    • (2000) Circulation. , vol.101 , pp. 590-593
    • Müller, C.1    Büttner, H.J.2    Petersen, J.3    Roskamm, H.4
  • 24
    • 0033404702 scopus 로고    scopus 로고
    • Clopidogrel as adjunctive antiplatelet therapy during coronary stenting
    • Mishkel GJ, Aguirre FV, Ligon RW, et al. Clopidogrel as adjunctive antiplatelet therapy during coronary stenting. J Am Coll Cardiol. 1999, 34:1884-1890.
    • (1999) J Am Coll Cardiol. , vol.34 , pp. 1884-1890
    • Mishkel, G.J.1    Aguirre, F.V.2    Ligon, R.W.3
  • 25
  • 26
    • 0032814002 scopus 로고    scopus 로고
    • Clopidogrel loading dose regimens: Kinetic profile of pharmacodynamic response in healthy subjects
    • Savcic M, Hauert J, Bachmann F, et al. Clopidogrel loading dose regimens: Kinetic profile of pharmacodynamic response in healthy subjects. Semin Thromb Hemost. 1999, 25(Suppl 2):15-19.
    • (1999) Semin Thromb Hemost. , vol.25 , Issue.SUPPL. 2 , pp. 15-19
    • Savcic, M.1    Hauert, J.2    Bachmann, F.3
  • 27
    • 29344457180 scopus 로고    scopus 로고
    • ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: A report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACQ AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
    • American College of Cardiology/American Heart Association Task Force on Practice Guidelines, ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary InterventionACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention
    • Smith SC, Feldman TE, Hirshfeld JW, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: A report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACQ AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). J Am Coll Cardiol. 2006, 47:e1-e121. American College of Cardiology/American Heart Association Task Force on Practice Guidelines, ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary InterventionACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention.
    • (2006) J Am Coll Cardiol. , vol.47
    • Smith, S.C.1    Feldman, T.E.2    Hirshfeld, J.W.3
  • 28
    • 20244377701 scopus 로고    scopus 로고
    • Guidelines for percutaneous coronary interventions
    • Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology
    • Silber S, Albertsson P, Avilés FF, et al. Guidelines for percutaneous coronary interventions. Eur Heart J. 2005, 26:804-847. Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology.
    • (2005) Eur Heart J. , vol.26 , pp. 804-847
    • Silber, S.1    Albertsson, P.2    Avilés, F.F.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.