Antithrombotic drug development for atrial fibrillation: Proceedings, Washington, DC, July 25-27, 2005

American Heart Journal

Volumn 155, Issue 5, 2008, Pages 829-840

  Jackson, Kevin ^a,f   Gersh, Bernard J ^b,f   Stockbridge, Norman ^c,f   Fleming, Thomas R ^d,f   Temple, Robert ^c,f   Califf, Robert M ^a,f   Connolly, Stuart J ^e,f   Wallentin, Lars ^e,f   Granger, Christopher B ^a,f  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b MAYO CLINIC   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

^e MCMASTER UNIVERSITY   (Canada)

^f UPPSALA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIVITAMIN K; CLOPIDOGREL; PLACEBO; WARFARIN; XIMELAGATRAN;

ANTICOAGULANT THERAPY; ARTERY THROMBOSIS; ARTICLE; BLEEDING; CLINICAL PRACTICE; COST EFFECTIVENESS ANALYSIS; DRUG POTENTIATION; EMBOLISM; EPIDEMIOLOGICAL DATA; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; METHODOLOGY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROPHYLAXIS; QUALITY ADJUSTED LIFE YEAR; REGISTER; RISK BENEFIT ANALYSIS; STANDARD; STROKE;

ATRIAL FIBRILLATION; DRUG DESIGN; FIBRINOLYTIC AGENTS; HUMANS; RESEARCH DESIGN; STROKE; WARFARIN;

EID: 42949104042     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2008.01.023     Document Type: Article

References (44)

1. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med 323 (1990) 1505-1511
2. Stroke Prevention in Atrial Fibrillation Investigators. Stroke prevention in atrial fibrillation study: final results. Circulation 84 (1991) 527-539
3. Ezekowitz M.D., Bridgers S.L., James K.E., et al. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators. N Engl J Med 327 (1992) 1406-1412
4. Connolly S.J., Laupacis A., Gent M., et al. Canadian Atrial Fibrillation Anticoagulation (CAFA) study. J Am Coll Cardiol 18 (1991) 349-355
5. European Atrial Fibrillation Trial (EAFT) Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet 342 (1993) 1255-1262
6. Petersen P., Boysen G., Godtfredsen J., et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1 (1989) 175-179
7. Hart R.G., Benavente O., McBride R., et al. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med 131 (1999) 492-501
8. Hart R.G., Pearce L.A., and Aguilar M.I. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 146 (2007) 857-867
9. Food and Drug Administration. Dockets home page. Available at:. http://www.fda.gov/ohrms/dockets/AC/04/briefing/2004-4069B1_07_FDA-Backg rounder-C-R-stat%20Review.pdf [Accessed 26 December 2007]
10. Stroke Prevention in Atrial Fibrillation Investigators. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II study. Lancet 343 (1994) 687-691
11. Fang M.C., Chang Y., Hylek E.M., et al. Advanced age, anticoagulation intensity, and risk for intracranial hemorrhage among patients taking warfarin for atrial fibrillation. Ann Intern Med 141 (2004) 745-752
12. Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation: analysis of pooled data from five randomized controlled trials. Arch Intern Med 154 (1994) 1449-1457
13. Eckman M.H., Levine H.J., and Pauker S.G. Effect of laboratory variation in the prothrombin-time ratio on the results of oral anticoagulant therapy. N Engl J Med 329 (1993) 696-702
14. 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 randomised controlled trial. Lancet 367 (2006) 1903-1912
15. Marini C., De Santis F., Sacco S., et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke 36 (2005) 1115-1119
16. Miyasaka Y., Barnes M.E., Gersh B.J., et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation 114 (2006) 119-125
17. Gurwitz J.H., Col N.F., and Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA 268 (1992) 1417-1422
18. Healey J., Baranchuk A., Crystal E., et al. Prevention of atrial fibrillation with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: a meta-analysis. J Am Coll Cardiol 45 (2005) 1832-1839
19. Siu C.W., Lau C.P., and Tse H.F. Prevention of atrial fibrillation recurrence by statin therapy in patients with lone atrial fibrillation after successful cardioversion. Am J Cardiol 92 (2003) 1343-1345
20. Sherman D.G., Kim S.G., Boop B.S., et al. Occurrence and characteristics of stroke events in the AFFIRM study. Arch Intern Med 165 (2005) 1185-1191
21. Go A.S., Hylek E.M., Borowsky L.H., et al. Warfarin use among ambulatory patients with nonvalvular atrial fibrillation: the anticoagulation and risk factors in atrial fibrillation (ATRIA) study. Ann Intern Med 131 (1999) 927-934
22. Bungard T.J., Ghali W.A., McAlister F.A., et al. Physicians' perceptions of the benefits and risks of warfarin for patients with nonvalvular atrial fibrillation. CMAJ 165 (2001) 301-302
23. Go A.S., Hylek E.M., Chang Y., et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice?. JAMA 290 (2003) 2685-2692
24. Matchar D.B., Samsa G.P., Cohen S.J., et al. Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: results of the managing anticoagulation services trial. Am J Med 113 (2002) 42-51
25. Hylek E.M., Chang Y., Skates S.J., et al. Prospective study of the outcomes of ambulatory patients with excessive warfarin anticoagulation. Arch Intern Med 160 (2000) 1612-1617
26. Garcia D., Regan S., Crowther M., et al. Warfarin maintenance dosing patterns in clinical practice: implications for safer anticoagulation in the elderly population. Chest 127 (2005) 2049-2056
27. Fleming T.R. Current issues in non-inferiority trials. Stat Med 27 (2008) 317-332
28. Atrial Fibrillation Investigators. The efficacy of aspirin in patients with atrial fibrillation: analysis of pooled data from 3 randomized trials. Arch Intern Med 157 (1997) 1237-1240
29. The Clopidogrel in Unstable Angina for Prevention of Recurrent Events (CURE) Trial Investigators. Effects of clopidogrel to addition with aspirin in patients with acute coronary syndrome without ST-segment elevation. N Engl J Med 345 (2001) 494-502
30. Hohnloser S.H., and Connolly S.J. Combined antiplatelet therapy in atrial fibrillation: review of the literature and future research avenues. J Cardiovasc Electrophysiol 14 9 Suppl (2003) S60-S63
31. National Institutes of Health. Evaluating the use of SR34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation. Available at:. http://clinicaltrials.gov/show/NCT00070655 [Accessed 18 July 2007]
32. Halperin J.L., Executive Steering Committee, and SPORTIF III and V Study Investigators. 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 146 (2003) 431-438
33. Mohapatra R., Tran M., Gore J.M., et al. A review of the oral direct thrombin inhibitor ximelagatran: not yet the end of the warfarin era. Am Heart J 150 (2005) 19-26
34. Hylek E.M., Go A.S., Chang Y., et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 349 (2003) 1019-1026
35. van Walraven C., Hart R.G., Singer D.E., et al. Oral anticoagulants versus aspirin in nonvalvular atrial fibrillation: an individual patient meta-analysis. JAMA 288 (2002) 2441-2448
36. Temple R., and Ellenburg S.S. Placebo-controlled trials and active-control trials in the evaluation of new treatments: Part 1. Ethical and scientific issues. Ann Intern Med 133 (2000) 455-463
37. Fuster V., Rydén L.E., Asinger R.W., et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol 38 (2001) 1231-1266
38. Gage B.F., Cardinalli A.B., and Owens D.K. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med 156 (1996) 1829-1836
39. O'Brien C.L., and Gage B.F. Costs and effectiveness of ximelagatran for stroke prophylaxis in chronic atrial fibrillation. JAMA 293 (2005) 699-706
40. Thomson R., Parkin D., Eccles M., et al. Decision analysis and guidelines for anticoagulant therapy to prevent stroke in patients with atrial fibrillation. Lancet 355 (2000) 956-962
41. Lancaster T.R., Singer D.E., Sheehan M.A., et al. The impact of long-term warfarin therapy on quality of life. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. Arch Intern Med 151 (1991) 1944-1949
42. ICH harmonized tripartite guideline. Choice of control group and related issues in clinical trials. E10. Current Step 4 version, dated 20 July 2000. Available at:. http://www.ich.org/LOB/media/MEDIA486.pdf [Accessed 17 July 2007]
43. Burke S.P., Blumenthal D., Breckenridge A., et al. Committee on the Assessment of the US Drug Safety System. In: Baciu A., Stratton K., and Burke S.P. (Eds). The Future of Drug Safety: Promoting and Protecting the Health of the Public (2007), Institute of Medicine of the National Academies/The National Academies Press, Washington (DC)
44. Platt R., and Ommaya A. A beneficial side effect of the Medicare drug benefit. N Engl J Med 353 (2005) 2742-2743