We have located links that may give you full text access.
CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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).
American Heart Journal 2003 September
BACKGROUND: Ximelagatran is a novel, oral direct thrombin inhibitor under investigation as an alternative to warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation (AF). Two long-term studies in patients with AF and at least one additional risk factor for stroke are underway to compare the safety and efficacy of fixed-dose ximelagatran (36 mg bid) without coagulation monitoring with dose-adjusted warfarin (international normalized ratio 2.0-3.0).
METHODS: SPORTIF III is a randomized, open-label, parallel-group study with blinded event assessment involving 3407 patients at 259 sites in 23 countries. SPORTIF V is similar, but with double-blind treatment allocation involving 3922 patients at 409 North American sites. The primary end point in each study is the incidence of all strokes and systemic embolic events, and the objective is to establish the noninferiority of ximelagatran relative to warfarin. Secondary end point constellations include (1) death, stroke, systemic embolism, and myocardial infarction; (2) ischemic stroke, transient ischemic attack, and systemic embolism; and (3) bleeding and treatment discontinuation. Blinded central committees adjudicate all end points and monitor patient safety. The studies commenced July 2000; enrollment ended in December 2001. Each study will accrue > or =4000 patient-years and > or =80 primary end points with a minimum per-patient exposure of 12 months. Combined analysis of both studies is also planned.
RESULTS: The demographics of the 2 patient populations are similar and should allow the studies to meet the objective.
CONCLUSIONS: The program, the largest conducted in this indication, will determine the safety and antithrombotic efficacy of ximelagatran as an alternative to warfarin for prevention of thromboembolism in patients with AF.
METHODS: SPORTIF III is a randomized, open-label, parallel-group study with blinded event assessment involving 3407 patients at 259 sites in 23 countries. SPORTIF V is similar, but with double-blind treatment allocation involving 3922 patients at 409 North American sites. The primary end point in each study is the incidence of all strokes and systemic embolic events, and the objective is to establish the noninferiority of ximelagatran relative to warfarin. Secondary end point constellations include (1) death, stroke, systemic embolism, and myocardial infarction; (2) ischemic stroke, transient ischemic attack, and systemic embolism; and (3) bleeding and treatment discontinuation. Blinded central committees adjudicate all end points and monitor patient safety. The studies commenced July 2000; enrollment ended in December 2001. Each study will accrue > or =4000 patient-years and > or =80 primary end points with a minimum per-patient exposure of 12 months. Combined analysis of both studies is also planned.
RESULTS: The demographics of the 2 patient populations are similar and should allow the studies to meet the objective.
CONCLUSIONS: The program, the largest conducted in this indication, will determine the safety and antithrombotic efficacy of ximelagatran as an alternative to warfarin for prevention of thromboembolism in patients with AF.
Full text links
Related Resources
Trending Papers
Heart failure with preserved ejection fraction: diagnosis, risk assessment, and treatment.Clinical Research in Cardiology : Official Journal of the German Cardiac Society 2024 April 12
Proximal versus distal diuretics in congestive heart failure.Nephrology, Dialysis, Transplantation 2024 Februrary 30
Efficacy and safety of pharmacotherapy in chronic insomnia: A review of clinical guidelines and case reports.Mental Health Clinician 2023 October
World Health Organization and International Consensus Classification of eosinophilic disorders: 2024 update on diagnosis, risk stratification, and management.American Journal of Hematology 2024 March 30
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app