VITATOPS, the VITAmins TO Prevent Stroke Trial: Rationale and Design of a Randomised Trial of B-Vitamin Therapy in Patients with Recent Transient Ischaemic Attack or Stroke (NCT00097669) (ISRCTN74743444)

Hankey, Graeme J.; Algra, A.; Chen, C.; Wong, Meng Cheong; Cheung, Rtf; Wong, Ka Sing; Divjak, Ivana; Ferro, José M.; Freitas, Gabriel; Gommans, John; Groppa, Sergiu; Hill, Michael D.; Spence, David J.; Lees, KR; Liu, Lisheng; Navarro, Josep; Ranawaka, Udaya K.; Ricci, Stefano; Schmidt, Reinhold; Slivka, Andrew; Tan, Kong Teng; Tsiskaridze, Alexander; Uddin, Wasim; Vanhooren, Geert; Xavier, Denis; Armitage, Jane; Hobbs, Michael; Le, M.; Sudlow, Cathie; Wheatley, K.; Yi, Qilong; Bulder, Marcel M M; Eikelboom, John W.; Ho, W.K.; Jamrozik, Konrad; Klijn, Catharina J.M.; Koedam, Esther; Langton, PD; Nijboer, E.; Tuch, P.; Pizzi, J.; Tang, Miaoling; Antenucci, Mirca; Chew, Yik Ling; Chinnery, D.; Cockayne, C.; Loh, Katherine; McMullin, L.; Smith, Fang Gao; Song, Swithin

doi:10.1111/j.1747-4949.2007.00111.x

Cited by 36 publications

(6 citation statements)

References 24 publications

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“…Trials are broken down into those that were successful and those that were not using our primary definition of successful. One trial had low conditional power towards the end of recruitment despite finding an effect larger than planned (relatively): this is due to the lack of statistical significance found by the trial, that is P -values of P = 0.050 [7]. This was due to the observed response rates being different than assumed.…”

Section: Resultsmentioning

confidence: 99%

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An investigation of the impact of futility analysis in publicly funded trials

Sully

Julious

Nicholl

2014

Trials

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BackgroundPublicly funded trials regularly fail to recruit their target sample size or find a significant positive result. Adaptive clinical trials which may partly mediate against the problems are not often applied. In this paper we investigate the potential of a form of adaption in a clinical trial - a futility analysis - to see if it has potential to improve publicly funded trials.MethodsOutcome data from trials funded by two UK bodies, the Health Technology Assessment (HTA) programme and the UK Medical Research Council (MRC), were collected. These data were then used to simulate each trial with a single futility analysis using conditional power, undertaken after 50% to 90% of the patients had been recruited. Thirty-three trials recruiting between 2002 and 2008 met the inclusion criteria. Stopping boundaries of conditional powers of 20%, 30% and 40% were considered and outcomes included the number of trials successfully stopped and number of patients saved.ResultsInclusion of a futility analysis after 75% of the patients had been recruited would have potentially resulted in 10 trials, which went on to have negative results, correctly stopping for futility using a stopping boundary of 30%. A total of 807 patients across all the trials would potentially have been saved using these futility parameters. The proportion of studies successfully recruiting would also have increased from 45% to 64%.ConclusionsA futility assessment has the potential to increase efficiency, save patients and decrease costs in publicly funded trials. While there are logistical issues in undertaking futility assessments we recommend that investigators should aim to include a futility analysis in their trial design wherever possible.

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Section: Resultsmentioning

confidence: 99%

“…This increases the complexity of the whole trial. These practicalities, along with slow recruitment, can have a negative impact on trial duration [7-9]. …”

Section: Introductionmentioning

confidence: 99%

An investigation of the impact of futility analysis in publicly funded trials

Sully

Julious

Nicholl

2014

Trials

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“…Elevated homocysteine likely represents a cardiovascular risk marker [32], although the results of a large homocysteine-lowering stroke prevention trial are pending [33]. It is not clear whether there might be a sex-differential impact of homocysteine on stroke risk.…”

Section: Discussionmentioning

confidence: 99%

Persistent Sex Disparity in Midlife Stroke Prevalence in the United States

Towfighi

Markovic²,

Ovbiagele

2011

Cerebrovasc Dis

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Background: A recent study found that US women aged 45–54 years in 1999–2004 were twice as likely as men to report previous stroke. The aim of this study was to evaluate the validity of this finding by assessing the sex-specific midlife stroke prevalence in the most recent nationally representative, cross-sectional sample of US individuals. Methods: Sex-specific stroke prevalence, sex-specific vascular risk factor prevalence and sex-specific independent predictors of stroke were assessed among 35- to 64-year olds who participated in the National Health and Nutrition Examination Surveys in 2005–2006 (n = 2,274). Results: Women aged 35–64 years were almost 3 times more likely than men to report prior stroke (2.90 vs. 1.07%; p < 0.001). This disparity was driven by the 45- to 54-year age group, where women had thrice the odds of prior stroke compared with men (OR 3.12, 95% CI 1.30–7.50). Among 45- to 54-year olds, men were more likely than women to have a history of smoking, elevated homocysteine and elevated triglyceride levels, but less likely to be abdominally obese (p < 0.001). Independent stroke risk factors among women aged 35–64 years were a homocysteine level >8.5 µmol/l (OR 6.19, 95% CI 2.57–14.93), a history of myocardial infarction (OR 5.35, 95% CI 1.09–26.27) and diabetes mellitus (OR 6.63, 95% CI 2.47–17.81). Conclusion: The midlife sex disparity in US stroke prevalence persists. Greater emphasis on prompt recognition and treatment of cardiovascular risk factors among young and middle-aged women may ameliorate this worrisome trend.

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“…Although there is a body of literature that investigates the role of nutritional supplementation as a method of primary prevention for stroke and cardiovascular disease (VITATOPS, HOPE-2, VISP, CSPPT, etc. ), only current literature relevant to acute and subacute stroke recovery will be discussed [34,35,36,37,38,39,40].…”

Section: Introductionmentioning

confidence: 99%

Nutrition, Energy Expenditure, Dysphagia, and Self-Efficacy in Stroke Rehabilitation: A Review of the Literature

et al. 2018

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While significant research has been performed regarding the use of thrombolytic agents and thrombectomy in the setting of acute stroke, other factors, such as nutritional status of stroke patients, is a less explored topic. The topic of nutrition is critical to the discussion of stroke, as up to half of stroke survivors may be considered malnourished at discharge. Dysphagia, old age, restricted upper limb movement, visuospatial impairment, and depression are all important risk factors for malnutrition in this cohort. The purpose of this review is to analyze current literature discussing neuroprotective diets, nutritional, vitamin, and mineral supplementation, dysphagia, and post-stroke coaching in stroke patients.

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VITATOPS, the VITAmins TO Prevent Stroke Trial: Rationale and Design of a Randomised Trial of B-Vitamin Therapy in Patients with Recent Transient Ischaemic Attack or Stroke (NCT00097669) (ISRCTN74743444)

Cited by 36 publications

References 24 publications

An investigation of the impact of futility analysis in publicly funded trials

An investigation of the impact of futility analysis in publicly funded trials

Persistent Sex Disparity in Midlife Stroke Prevalence in the United States

Nutrition, Energy Expenditure, Dysphagia, and Self-Efficacy in Stroke Rehabilitation: A Review of the Literature

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