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- Connolly, S., et al.
(author)
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Rationale and design of ACTIVE: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events
- 2006
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In: American heart journal. - 1097-6744. ; 151:6, s. 1187-93
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Journal article (peer-reviewed)abstract
- BACKGROUND: Atrial fibrillation (AF) is the most frequently occurring cardiac arrhythmia with often serious clinical consequences. Many patients have contraindications to anticoagulation, and it is often underused in clinical practice. The addition of clopidogrel to aspirin (ASA) has been shown to reduce vascular events in a number of high-risk populations. Irbesartan is an angiotensin receptor-blocking agent that reduces blood pressure and has other vascular protective effects. METHODS AND RESULTS: ACTIVE W is a noninferiority trial of clopidogrel plus ASA versus oral anticoagulation in patients with AF and at least 1 risk factor for stroke. ACTIVE A is a double-blind, placebo-controlled trial of clopidogrel in patients with AF and with at least 1 risk factor for stroke who receive ASA because they have a contraindication for oral anticoagulation or because they are unwilling to take an oral anticoagulant. ACTIVE I is a partial factorial, double-blind, placebo-controlled trial of irbesartan in patients participating in ACTIVE A or ACTIVE W. The primary outcomes of these studies are composites of vascular events. A total of 14000 patients will be enrolled in these trials. CONCLUSIONS: ACTIVE is the largest trial yet conducted in AF. Its results will lead to a new understanding of the role of combined antiplatelet therapy and the role of blood pressure lowering with an angiotensin II receptor blocker in patients with AF.
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- Quinn, M, et al.
(author)
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History, scope and methodology of the 3rd International Consensus Workshop on Ovarian Cancer 2004.
- 2005
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In: Annals of Oncology. - : Oxford University Press. - 0923-7534 .- 1569-8041. ; 16:8, s. viii5-viii6
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Journal article (peer-reviewed)abstract
- This document reports the history of the two previous ovarian cancer consensus meetings and the scope and methodology of the 3rd International Ovarian Cancer Consensus Conference, which was held by the GCIG from 5–9 September 2004 in Baden-Baden, Germany. This conference was supported by an unrestricted grant from Bristol-Myers-Squibb. Selection of participants, agenda and deliberations were not influenced by the financial support provider.
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- Harrington, Robert A., et al.
(author)
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The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA.CER) trial : study design and rationale
- 2009
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 158:3, s. 327-334
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Journal article (peer-reviewed)abstract
- Background The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA.CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. Trial design TRA.CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least I year. The TRA.CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. Conclusion TRA.CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.
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| 8. |
- Vermorken, J B, et al.
(author)
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The Gynecologic Cancer Intergroup (GCIG) : history and current status.
- 2005
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In: Annals of Oncology. - : Oxford University Press. - 0923-7534 .- 1569-8041. ; 16:8, s. viii39-viii42
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Journal article (peer-reviewed)abstract
- Randomized trials are considered the definitive source of evidence for guiding decisions in clinical practice, especially when the magnitude of the expected treatment difference is at best moderate. Goals of these trials are (i) to determine the effectiveness of a treatment relative to the best current standard of care, or (ii) to assess whether a new treatment is as effective as the standard, but associated with less toxicity, cost or better quality of life. The design, execution and analysis of such trials must be based on sound scientific and ethical criteria, but it is also crucial that they have sufficient statistical power to detect a realistic and clinically important difference in overall or progression-free survival [1]. Lack of statistical power owing to small numbers of enrolled patients has been a serious problem in ovarian cancer trials in the past. Both progression-free and overall survival can be considered as important end points (although progressionfree survival is also often considered as a surrogate end point for survival) and are of obvious clinical relevance for the patients, just as are quality of life or symptoms scores
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