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Volumn 6, Issue 3, 2009, Pages 239-251

Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; CLOPIDOGREL; ENOXAPARIN; FOLIC ACID; FONDAPARINUX; HEPARIN; HIRUDIN; PLACEBO; RAMIPRIL; REVIPARIN;

EID: 67649383249     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509105223     Document Type: Article
Times cited : (98)

References (30)
  • 1
    • 0031079743 scopus 로고    scopus 로고
    • Outcome assessment for clinical trials: How many adjudicators do we need?
    • (for the Canadian Lung Oncology Group)
    • Walter SD, Cook DJ, Guyatt GH, King D., Troyan S. (for the Canadian Lung Oncology Group). Outcome assessment for clinical trials: How many adjudicators do we need? Control Clin Trials 1997; 18: 27-42.
    • (1997) Control Clin Trials , vol.18 , pp. 27-42
    • Walter, S.D.1    Cook, D.J.2    Guyatt, G.H.3    King, D.4    Troyan, S.5
  • 2
    • 45149137528 scopus 로고
    • The operation of a central adjudication committee and its effect on the validity of the assessment of treatment benefit
    • Sicurella J., Roberts R., Gent M. The operation of a central adjudication committee and its effect on the validity of the assessment of treatment benefit. Control Clin Trials 1990; 11: 283.
    • (1990) Control Clin Trials , vol.11 , pp. 283
    • Sicurella, J.1    Roberts, R.2    Gent, M.3
  • 3
    • 0035455598 scopus 로고    scopus 로고
    • Differences in difficultly adjudicating clinical events in patients with advanced HIV disease
    • (for the Viral Activation Transfusion Study (VATS) Group)
    • Eisenbud R., Assman SF, Kalish LA et al. Differences in difficultly adjudicating clinical events in patients with advanced HIV disease (for the Viral Activation Transfusion Study (VATS) Group). J Immune Defic Syndr 2001; 28: 43-6.
    • (2001) J Immune Defic Syndr , vol.28 , pp. 43-46
    • Eisenbud, R.1    Assman, S.F.2    Kalish, L.A.3
  • 5
    • 0032531113 scopus 로고    scopus 로고
    • Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients
    • Cook DJ, Walter SD, Cook RJ et al. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med 1998; 129: 433-40.
    • (1998) Ann Intern Med , vol.129 , pp. 433-440
    • Cook, D.J.1    Walter, S.D.2    Cook, R.J.3
  • 6
    • 17944370493 scopus 로고    scopus 로고
    • Systematic adjudication of myocardial infarction end-points in an international clinical trial
    • (for the PURSUIT Investigators)
    • Mahaffey KW, Harrington RA, Akkerhuis M. et al. (for the PURSUIT Investigators). Systematic adjudication of myocardial infarction end-points in an international clinical trial. Curr Control Trials Cardiovasc Med 2001; 2: 180-86.
    • (2001) Curr Control Trials Cardiovasc Med , vol.2 , pp. 180-186
    • Mahaffey, K.W.1    Harrington, R.A.2    Akkerhuis, M.3
  • 7
    • 0036480190 scopus 로고    scopus 로고
    • Misreporting of myocardial infarction end points: Results of adjudication by a central clinical events committee in the PARAGON-B trial
    • the (for PARAGON-B Investigators)
    • Mahaffey KW, Roe MT, Dyke CK et al. (for the PARAGON-B Investigators). Misreporting of myocardial infarction end points: Results of adjudication by a central clinical events committee in the PARAGON-B trial. Am Heart J 2002; 143: 242-48.
    • (2002) Am Heart J , vol.143 , pp. 242-248
    • Mahaffey, K.W.1    Roe, M.T.2    Dyke, C.K.3
  • 8
    • 0344394946 scopus 로고    scopus 로고
    • Blinded end point adjudication in the 'Danish Multicenter Randomized Study on Fibrinolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infarction' (DANAMI-2 trial)
    • (on behalf of the DANAMI-2 investigators)
    • Vejlstrup N., Clemmensen P., Steinmetz E. et al. (on behalf of the DANAMI-2 investigators). Blinded end point adjudication in the 'Danish Multicenter Randomized Study on Fibrinolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infarction' (DANAMI-2 trial). Heart Drug 2003; 3: 127-33.
    • (2003) Heart Drug , vol.3 , pp. 127-133
    • Vejlstrup, N.1    Clemmensen, P.2    Steinmetz, E.3
  • 9
    • 33646180879 scopus 로고    scopus 로고
    • Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee
    • (MOST Clinical Events Committee)
    • Petersen JL, Haque G., Hellkamp AS et al. (MOST Clinical Events Committee). Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials 2006; 27: 260-68.
    • (2006) Contemp Clin Trials , vol.27 , pp. 260-268
    • Petersen, J.L.1    Haque, G.2    Hellkamp, A.S.3
  • 10
    • 0033135701 scopus 로고    scopus 로고
    • The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: Results with and without the end-point committee's final decision on end-points
    • Naslund U., Grip L., Fischer-Hansen J. et al. The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: Results with and without the end-point committee's final decision on end-points. Eur Heart J 1999; 20: 771-7.
    • (1999) Eur Heart J , vol.20 , pp. 771-777
    • Naslund, U.1    Grip, L.2    Fischer-Hansen, J.3
  • 11
    • 40949163394 scopus 로고    scopus 로고
    • Do we need to adjudicate major clinical events?
    • Granger CB, Vogel V., Cummings SR et al. Do we need to adjudicate major clinical events? Clin Trials 2008; 5:56- 60.
    • (2008) Clin Trials , vol.5 , pp. 56-60
    • Granger, C.B.1    Vogel, V.2    Cummings, S.R.3
  • 12
    • 0030919511 scopus 로고    scopus 로고
    • Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention - IMPACT-II
    • The IMPACT-II Investigators
    • The IMPACT-II Investigators. Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention - IMPACT-II. Lancet 1997; 349: 1422-8.
    • (1997) Lancet , vol.349 , pp. 1422-1428
  • 13
    • 0029835392 scopus 로고    scopus 로고
    • A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes
    • The GUSTO-Iib Investigators
    • The GUSTO-Iib Investigators. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes. N Engl J Med 1996; 335: 775-82.
    • (1996) N Engl J Med , vol.335 , pp. 775-782
  • 14
    • 0041408234 scopus 로고    scopus 로고
    • Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: The CHARM-Preserved Trial
    • (CHARM Investigators and Committees)
    • Yusuf S., Pfeffer MA, Swedberg K. et al. (CHARM Investigators and Committees). Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: The CHARM-Preserved Trial. Lancet 2003; 362: 777-81.
    • (2003) Lancet , vol.362 , pp. 777-781
    • Yusuf, S.1    Pfeffer, M.A.2    Swedberg, K.3
  • 15
    • 2242477091 scopus 로고
    • Use of a monoclonal antibody directed against the platelet glycoprotein Iib/IIIa receptor in high-risk coronary angioplasty
    • The EPIC Investigators
    • The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein Iib/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994; 330: 956-61.
    • (1994) N Engl J Med , vol.330 , pp. 956-961
  • 16
    • 0343580449 scopus 로고    scopus 로고
    • A pilot study to assess the effects of two doses of recombinant hirudin compared to heparin in patients with acute myocardial ischemia without ST elevation
    • Organization to assess strategies for ischemic syndromes (OASIS) investigator
    • Organization to assess strategies for ischemic syndromes (OASIS) investigator. A pilot study to assess the effects of two doses of recombinant hirudin compared to heparin in patients with acute myocardial ischemia without ST elevation. Circulation 1997; 96: 769-77.
    • (1997) Circulation , vol.96 , pp. 769-777
  • 17
    • 0032530662 scopus 로고    scopus 로고
    • Long-term oral anticoagulant therapy in patients with unstable angina or suspected non-Q wave MI: Organization to Assess Strategies for Ischemic Syndomes (OASIS) pilot study results
    • (for the OASIS Pilot Study Investigators)
    • Anand S., Yusuf S., Pogue J., Weitz J., Flather M. (for the OASIS Pilot Study Investigators). Long-term oral anticoagulant therapy in patients with unstable angina or suspected non-Q wave MI: Organization to Assess Strategies for Ischemic Syndomes (OASIS) pilot study results. Circulation 1998; 98: 1064-70.
    • (1998) Circulation , vol.98 , pp. 1064-1070
    • Anand, S.1    Yusuf, S.2    Pogue, J.3    Weitz, J.4    Flather, M.5
  • 18
    • 0034688194 scopus 로고    scopus 로고
    • Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high- risk patients
    • The Heart Outcomes Prevention Evaluation Study Investigators
    • The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high- risk patients. N Engl J Med 2000; 342(3): 145-53.
    • (2000) N Engl J Med , vol.342 , Issue.3 , pp. 145-153
  • 19
    • 0033528281 scopus 로고    scopus 로고
    • Effects of recombinant hirudin (lepirudin) compared with heparin on death, myocardial infarction, refractory angina, and revascularisation procedures in patients with acute myocardial ischaemia without ST elevation: A randomised trial
    • Organisation to Assess Strategies for Ischemic Syndromes (OASIS-2) Investigators
    • Organisation to Assess Strategies for Ischemic Syndromes (OASIS-2) Investigators. Effects of recombinant hirudin (lepirudin) compared with heparin on death, myocardial infarction, refractory angina, and revascularisation procedures in patients with acute myocardial ischaemia without ST elevation: A randomised trial. Lancet 1999; 353: 429 - 38.
    • (1999) Lancet , vol.353 , pp. 429-438
  • 20
    • 0035899289 scopus 로고    scopus 로고
    • Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation
    • The Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) Trial Investigators
    • The Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345: 494-502.
    • (2001) N Engl J Med , vol.345 , pp. 494-502
  • 21
    • 12544249141 scopus 로고    scopus 로고
    • Effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation
    • (CREATE Trial Group Investigators)
    • Yusuf S., Mehta SR, Xie C. et al. (CREATE Trial Group Investigators). Effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation. J Am Med Assoc 2005; 293: 427-35.
    • (2005) J Am Med Assoc , vol.293 , pp. 427-435
    • Yusuf, S.1    Mehta, S.R.2    Xie, C.3
  • 22
    • 33645753544 scopus 로고    scopus 로고
    • Homocysteine lowering with folic acid and B vitamins in vascular disease
    • (Heart Outcomes Evaluation (HOPE) 2 Investigators)
    • Lonn E., Yusuf S., Arnold MJ et al. (Heart Outcomes Evaluation (HOPE) 2 Investigators). Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med 2006; 354: 1567-77.
    • (2006) N Engl J Med , vol.354 , pp. 1567-1577
    • Lonn, E.1    Yusuf, S.2    Arnold, M.J.3
  • 23
    • 33645498094 scopus 로고    scopus 로고
    • Comparison of fondaparinux and enoxaparin in acute coronary syndromes
    • (Fifth Organization to Assess Strategies in Acute Ischemic Syndrome Investigators)
    • Yusuf S., Mehta SR, Chrolavicius S. et al. (Fifth Organization to Assess Strategies in Acute Ischemic Syndrome Investigators). Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354: 1464-76.
    • (2006) N Engl J Med , vol.354 , pp. 1464-1476
    • Yusuf, S.1    Mehta, S.R.2    Chrolavicius, S.3
  • 24
    • 33645497961 scopus 로고    scopus 로고
    • Effect of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: The OASIS-6 randomized trial
    • (OASIS-6 Trial Group)
    • Yusuf S., Mehta SR, Chrolavicius S. et al. (OASIS-6 Trial Group). Effect of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: The OASIS-6 randomized trial. J Am Med Assoc 2006; 295: 1519-30.
    • (2006) J Am Med Assoc , vol.295 , pp. 1519-1530
    • Yusuf, S.1    Mehta, S.R.2    Chrolavicius, S.3
  • 25
    • 33744945247 scopus 로고    scopus 로고
    • Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): A randomized controlled trial
    • (ACTIVE Writing Group on behalf of the ACTIVE Investigators)
    • Connolly S., Pogue J., Hart R. et al. (ACTIVE Writing Group on behalf of the ACTIVE Investigators). Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): A randomized controlled trial. Lancet 2006; 367: 1903-12.
    • (2006) Lancet , vol.367 , pp. 1903-1912
    • Connolly, S.1    Pogue, J.2    Hart, R.3
  • 26
    • 34447502152 scopus 로고    scopus 로고
    • Oral anticoagulant and antiplatelet therapy and peripheral arterial disease
    • (Warfarin Antiplatelet Vascular Evaluation Trial Investigators)
    • Anand S., Yusuf S., Xie C. et al. (Warfarin Antiplatelet Vascular Evaluation Trial Investigators). Oral anticoagulant and antiplatelet therapy and peripheral arterial disease. N Engl J Med 2007; 357: 217-27.
    • (2007) N Engl J Med , vol.357 , pp. 217-227
    • Anand, S.1    Yusuf, S.2    Xie, C.3
  • 27
    • 79951788153 scopus 로고    scopus 로고
    • SAS Institute Inc. Cary, NC: SAS Institute Inc
    • SAS Institute Inc. SAS 9.1. Cary, NC: SAS Institute Inc; 2002.
    • (2002) SAS 9.1
  • 28
    • 33644876849 scopus 로고    scopus 로고
    • Mortality and morbidity remain high despite captopril and/or Valsartan therapy in elderly patients with left ventricular systolic dysfunction, heart failure, or both after acute myocardial infarction: Results from the Valsartan in Acute Myocardial Infarction Trial (VALIANT)
    • (VALIANT Investigators)
    • White HD, Aylward PE, Huang Z. et al. (VALIANT Investigators). Mortality and morbidity remain high despite captopril and/or Valsartan therapy in elderly patients with left ventricular systolic dysfunction, heart failure, or both after acute myocardial infarction: Results from the Valsartan in Acute Myocardial Infarction Trial (VALIANT). Circulation 2005; 112: 3391-9.
    • (2005) Circulation , vol.112 , pp. 3391-3399
    • White, H.D.1    Aylward, P.E.2    Huang, Z.3
  • 29
    • 20844444592 scopus 로고    scopus 로고
    • Effect of candesartan on cause-specific mortality in heart failure patients: The Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (CHARM) program
    • Solomon SD, Wang D., Finn P. et al. Effect of candesartan on cause-specific mortality in heart failure patients: The Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (CHARM) program. Circulation 2004; 110: 2180-3.
    • (2004) Circulation , vol.110 , pp. 2180-2183
    • Solomon, S.D.1    Wang, D.2    Finn, P.3
  • 30
    • 0344373794 scopus 로고    scopus 로고
    • Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs. diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
    • The ALLHAT officers, & Coordinators for the ALLHAT Collaborative Research Group
    • The ALLHAT officers, & Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs. diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981-97.
    • (2002) JAMA , vol.288 , pp. 2981-2997


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