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Volumn 109, Issue 3, 2013, Pages 497-503

Do open label blinded outcome studies of novel anticoagulants versus warfarin have equivalent validity to those carried out under double-blind conditions?

Author keywords

Clinical studies; Coagulation inhibitors; Management of disease; Metaanalysis; Thrombosis

Indexed keywords

ANTICOAGULANT AGENT; APIXABAN; DABIGATRAN; IDRAPARINUX; RIVAROXABAN; WARFARIN; XIMELAGATRAN;

EID: 84874760694     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH12-10-0715     Document Type: Article
Times cited : (19)

References (25)
  • 1
    • 34347394385 scopus 로고    scopus 로고
    • Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation
    • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146: 857-867.
    • (2007) Ann Intern Med , vol.146 , pp. 857-867
    • Hart, R.G.1    Pearce, L.A.2    Aguilar, M.I.3
  • 2
    • 80155179455 scopus 로고    scopus 로고
    • Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients
    • Gallagher AM, Setakis E, Plumb JM, et al. Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 2011; 106: 968-977.
    • (2011) Thromb Haemost , vol.106 , pp. 968-977
    • Gallagher, A.M.1    Setakis, E.2    Plumb, J.M.3
  • 3
    • 79960076271 scopus 로고    scopus 로고
    • Ischaemic stroke and bleeding rates in 'real-world' atrial fibrillation patients
    • Ogilvie IM, Welner SA, Cowell W, et al. Ischaemic stroke and bleeding rates in 'real-world' atrial fibrillation patients. Thromb Haemost 2011; 106: 34-44.
    • (2011) Thromb Haemost , vol.106 , pp. 34-44
    • Ogilvie, I.M.1    Welner, S.A.2    Cowell, W.3
  • 4
    • 84861753658 scopus 로고    scopus 로고
    • Oral anticoagulation use by patients with atrial fibrillation in Germany. Adherence to guidelines, causes of anticoagulation under-use and its clinical outcomes, based on claims-data of 183,448 patients
    • Wilke T, Groth A, Mueller S, et al. Oral anticoagulation use by patients with atrial fibrillation in Germany. Adherence to guidelines, causes of anticoagulation under-use and its clinical outcomes, based on claims-data of 183,448 patients. Thromb Haemost 2012; 107: 1053-1065.
    • (2012) Thromb Haemost , vol.107 , pp. 1053-1065
    • Wilke, T.1    Groth, A.2    Mueller, S.3
  • 5
    • 79953901937 scopus 로고    scopus 로고
    • What do the RE-LY, AVERROES and ROCKET-AF trials tell us for stroke prevention in atrial fibrillation?
    • Ahrens I, Lip GY, Peter K. What do the RE-LY, AVERROES and ROCKET-AF trials tell us for stroke prevention in atrial fibrillation? Thromb Haemost 2011; 105: 574-578.
    • (2011) Thromb Haemost , vol.105 , pp. 574-578
    • Ahrens, I.1    Lip, G.Y.2    Peter, K.3
  • 6
    • 38349144014 scopus 로고    scopus 로고
    • Open-label trials and drug registration: A European regulator's view
    • Casteels M, Flamion B. Open-label trials and drug registration: a European regulator's view. J Thromb Haemost 2008; 6: 232-234.
    • (2008) J Thromb Haemost , vol.6 , pp. 232-234
    • Casteels, M.1    Flamion, B.2
  • 7
    • 0034997768 scopus 로고    scopus 로고
    • Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators
    • Sever PS, Dahlof B, Poulter NR, et al. Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators. J Hypertens 2001; 19: 1139-1147.
    • (2001) J Hypertens , vol.19 , pp. 1139-1147
    • Sever, P.S.1    Dahlof, B.2    Poulter, N.R.3
  • 8
    • 0026911107 scopus 로고
    • Prospective randomized open blinded endpoint (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point
    • Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded endpoint (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press 1992; 1: 113-119.
    • (1992) Blood Press , vol.1 , pp. 113-119
    • Hansson, L.1    Hedner, T.2    Dahlof, B.3
  • 9
    • 0043095587 scopus 로고    scopus 로고
    • Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as doubleblind, placebo-controlled trials with respect to ABPM measurements
    • Smith DH, Neutel JM, Lacourciere Y, et al. Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as doubleblind, placebo-controlled trials with respect to ABPM measurements. J Hypertens 2003; 21: 1291-1298.
    • (2003) J Hypertens , vol.21 , pp. 1291-1298
    • Smith, D.H.1    Neutel, J.M.2    Lacourciere, Y.3
  • 10
    • 38349088957 scopus 로고    scopus 로고
    • Double-blind studies are not always optimum for evaluation of a novel therapy: The case of new anticoagulants
    • Buller HR, Halperin JL, Bounameaux H, et al. Double-blind studies are not always optimum for evaluation of a novel therapy: the case of new anticoagulants. J Thromb Haemost 2008; 6: 227-229.
    • (2008) J Thromb Haemost , vol.6 , pp. 227-229
    • Buller, H.R.1    Halperin, J.L.2    Bounameaux, H.3
  • 12
    • 77649254746 scopus 로고    scopus 로고
    • Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment
    • Eikelboom JW, O'Donnell M, Yusuf S, et al. Rationale and design of AVERROES: apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment. Am Heart J 2010; 159: 348-353.
    • (2010) Am Heart J , vol.159 , pp. 348-353
    • Eikelboom, J.W.1    O'Donnell, M.2    Yusuf, S.3
  • 13
    • 64349107688 scopus 로고    scopus 로고
    • Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran
    • Ezekowitz MD, Connolly S, Parekh A, et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J 2009; 157: 805-810.
    • (2009) Am Heart J , vol.157 , pp. 805-810
    • Ezekowitz, M.D.1    Connolly, S.2    Parekh, A.3
  • 14
    • 40749160810 scopus 로고    scopus 로고
    • Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: A randomised, open-label, non-inferiority trial
    • Bousser MG, Bouthier J, Buller HR, et al. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. Lancet 2008; 371: 315-321.
    • (2008) Lancet , vol.371 , pp. 315-321
    • Bousser, M.G.1    Bouthier, J.2    Buller, H.R.3
  • 15
    • 0041694480 scopus 로고    scopus 로고
    • Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V)
    • Halperin JL. Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V). Am Heart J 2003; 146: 431-438.
    • (2003) Am Heart J , vol.146 , pp. 431-438
    • Halperin, J.L.1
  • 16
    • 70349306707 scopus 로고    scopus 로고
    • Dabigatran versus warfarin in patients with atrial fibrillation
    • Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151.
    • (2009) N Engl J Med , vol.361 , pp. 1139-1151
    • Connolly, S.J.1    Ezekowitz, M.D.2    Yusuf, S.3
  • 17
    • 78049490509 scopus 로고    scopus 로고
    • Newly identified events in the RE-LY trial
    • Connolly SJ, Ezekowitz MD, Yusuf S, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363: 1875-1876.
    • (2010) N Engl J Med , vol.363 , pp. 1875-1876
    • Connolly, S.J.1    Ezekowitz, M.D.2    Yusuf, S.3
  • 18
    • 0345414673 scopus 로고    scopus 로고
    • Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): Randomised controlled trial
    • Executive Steering Committee of the SPORTIF III Investigators
    • Olsson SB, Executive Steering Committee of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003; 362: 1691-1698.
    • (2003) Lancet , vol.362 , pp. 1691-1698
    • Olsson, S.B.1
  • 19
    • 85058721877 scopus 로고    scopus 로고
    • Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: Rationale and design of the ROCKET AF study
    • Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J 2010; 159: 340-347.
    • (2010) Am Heart J , vol.159 , pp. 340-347
  • 20
    • 77649249878 scopus 로고    scopus 로고
    • Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: Design and rationale
    • Lopes RD, Alexander JH, Al-Khatib SM, et al. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J 2010; 159: 331-339.
    • (2010) Am Heart J , vol.159 , pp. 331-339
    • Lopes, R.D.1    Alexander, J.H.2    Al-Khatib, S.M.3
  • 21
    • 13444309949 scopus 로고    scopus 로고
    • Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: A randomized trial
    • Albers GW, Diener HC, Frison L, et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. J Am Med Assoc 2005; 293: 690-698.
    • (2005) J Am Med Assoc , vol.293 , pp. 690-698
    • Albers, G.W.1    Diener, H.C.2    Frison, L.3
  • 22
    • 80052592404 scopus 로고    scopus 로고
    • Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
    • Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-891.
    • (2011) N Engl J Med , vol.365 , pp. 883-891
    • Patel, M.R.1    Mahaffey, K.W.2    Garg, J.3
  • 23
    • 77957699729 scopus 로고    scopus 로고
    • Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC)
    • Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010; 31: 2369-2429.
    • (2010) Eur Heart J , vol.31 , pp. 2369-2429
    • Camm, A.J.1    Kirchhof, P.2    Lip, G.Y.3
  • 25
    • 80052825103 scopus 로고    scopus 로고
    • Apixaban versus warfarin in patients with atrial fibrillation
    • Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-992.
    • (2011) N Engl J Med , vol.365 , pp. 981-992
    • Granger, C.B.1    Alexander, J.H.2    McMurray, J.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.