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All Outputs (259)

Impact of atrial fibrillation diagnosis or carotid enderterectomy requirement on outcome in patients from the triple antiplatelets for reducing dependency after ischaemic stroke (TARDIS) trial (2018)
Conference Proceeding
Woodhouse, L. J., Appleton, J. P., Flaherty, K., Dineen, R. A., Sprigg, N., & Bath, P. M. (2018). Impact of atrial fibrillation diagnosis or carotid enderterectomy requirement on outcome in patients from the triple antiplatelets for reducing dependency after ischaemic stroke (TARDIS) trial.

Small vessels, dementia and chronic diseases – molecular mechanisms and pathophysiology (2018)
Journal Article
Horsburgh, K., Wardlaw, J. M., van Agtmael, T., Allan, S. M., Ashford, M. L., Bath, P. M., …Work, L. M. (2018). Small vessels, dementia and chronic diseases – molecular mechanisms and pathophysiology. Clinical Science, 132(8), https://doi.org/10.1042/CS20171620

Cerebral small vessel disease (SVD) is a major contributor to stroke, cognitive impairment and dementia with limited therapeutic interventions. There is a critical need to provide mechanistic insight and improve translation between pre-clinical resea... Read More about Small vessels, dementia and chronic diseases – molecular mechanisms and pathophysiology.

PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke: rationale and design of a randomised, open, phase III, clinical trial with blinded outcome assessment (2018)
Journal Article
Reinink, H., de Jonge, J. C., Bath, P. M., van de Beek, D., Berge, E., Borregaard, S., …van der Worp, B. (in press). PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke: rationale and design of a randomised, open, phase III, clinical trial with blinded outcome assessment. European Stroke Journal, https://doi.org/10.1186/ISRCTN82217627

Background: Elderly patients are at high risk of complications after stroke, such as infections and fever. The occurrence of these complications has been associated with an increased risk of death or dependency. Hypothesis: Prevention of aspiration,... Read More about PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke: rationale and design of a randomised, open, phase III, clinical trial with blinded outcome assessment.

Lipid-lowering pretreatment and outcome following intravenous thrombolysis for acute ischaemic stroke: a post hoc analysis of the enhanced control of hypertension and thrombolysis stroke study trial (2018)
Journal Article
Minhas, J. S., Wang, X., Arima, H., Bath, P. M., Billot, L., Broderick, J. P., …Robinson, T. G. (in press). Lipid-lowering pretreatment and outcome following intravenous thrombolysis for acute ischaemic stroke: a post hoc analysis of the enhanced control of hypertension and thrombolysis stroke study trial. Cerebrovascular Diseases, 45(5-6), https://doi.org/10.1159/000488911

Background: Debate exists as to whether statin pretreatment confers an increased risk of 90-day mortality and symptomatic intracranial haemorrhage (sICH) in acute ischaemic stroke (AIS) patients treated with intravenous thrombolysis. We assessed the... Read More about Lipid-lowering pretreatment and outcome following intravenous thrombolysis for acute ischaemic stroke: a post hoc analysis of the enhanced control of hypertension and thrombolysis stroke study trial.

Haemostatic therapies for acute spontaneous intracerebral haemorrhage (2018)
Journal Article
Al-Shahi Salman, R., Law, Z. K., Bath, P. M., Steiner, T., & Sprigg, N. (2018). Haemostatic therapies for acute spontaneous intracerebral haemorrhage. Cochrane Database of Systematic Reviews, Article CD005951. https://doi.org/10.1002/14651858.CD005951.pub4

Background: Outcome after spontaneous (non-traumatic) intracerebral haemorrhage (ICH) is influenced by haematoma volume; up to one-third of ICHs enlarge within 24 hours of onset. Early haemostatic therapy might improve outcome by limiting haematoma g... Read More about Haemostatic therapies for acute spontaneous intracerebral haemorrhage.

Clinical utility of remote platelet function measurement using P-selectin: assessment of aspirin, clopidogrel and prasugrel, and bleeding disorders (2018)
Journal Article
Bath, P. M., May, J., & Heptinstall, S. (2018). Clinical utility of remote platelet function measurement using P-selectin: assessment of aspirin, clopidogrel and prasugrel, and bleeding disorders. Platelets, 29(5), 425-430. https://doi.org/10.1080/09537104.2018.1445839

Vascular diseases such as myocardial infarction and ischaemic stroke are associated with increased platelet function whilst the risk of recurrence is reduced by antiplatelet agents such as aspirin, clopidogrel and prasugrel. However, some patients ex... Read More about Clinical utility of remote platelet function measurement using P-selectin: assessment of aspirin, clopidogrel and prasugrel, and bleeding disorders.

The effectiveness and safety of antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 2; peer review: 2 approved] (2018)
Journal Article
Ker, K., Prieto-Merino, D., Sprigg, N., Mahmood, A., Bath, P. M., Kang Law, Z., …Roberts, I. (2018). The effectiveness and safety of antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 2; peer review: 2 approved]. Wellcome Open Research, Article 120. https://doi.org/10.12688/wellcomeopenres.13262.2

© 2018 Ker K et al. Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials.... Read More about The effectiveness and safety of antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 2; peer review: 2 approved].

Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ (2018)
Journal Article
Scutt, P., Appleton, J. P., Dixon, M., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., …Bath, P. M. (2018). Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’. European Stroke Journal, 3(2), 193-196. https://doi.org/10.1177/2396987318756696

Rationale: Glyceryl trinitrate, a nitric oxide donor, is a candidate treatment for acute stroke; it lowers blood pressure, does not alter cerebral blood flow or platelet function and is neuroprotective in experimental stroke. The ongoing rapid interv... Read More about Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’.

Does tranexamic acid lead to changes in MRI-measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? An MRI sub-study nested within the double-blind randomised controlled TICH-2 trial (2018)
Journal Article
Dineen, R. A., Pszczolkowski, S., Flaherty, K., Law, Z. K., Morgan, P. S., Roberts, I., …Sprigg, N. (in press). Does tranexamic acid lead to changes in MRI-measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? An MRI sub-study nested within the double-blind randomised controlled TICH-2 trial. BMJ Open, 8(2), Article e019930. https://doi.org/10.1136/bmjopen-2017-019930

Objectives: To test whether administration of the antifibrinolytic drug tranexamic acid (TXA) in patients with spontaneous intracerebral haemorrhage (SICH) leads to increased prevalence of diffusion-weighted MRI defined hyperintense ischaemic lesions... Read More about Does tranexamic acid lead to changes in MRI-measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? An MRI sub-study nested within the double-blind randomised controlled TICH-2 trial.

Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial (2017)
Journal Article
Flaherty, K., Bath, P. M., Dineen, R., Law, Z., Scutt, P., Pocock, S., & Sprigg, N. (in press). Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial. Trials, 18(1), Article 607. https://doi.org/10.1186/s13063-017-2341-5

Rationale Aside from blood pressure lowering, treatment options for intracerebral haemorrhage remain limited and a proportion of patients will undergo early haematoma expansion with resultant significant morbidity and mortality. Tranexamic acid (T... Read More about Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial.

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial (2017)
Journal Article
Bath, P. M., Christensen, L. M., Woodhouse, L. J., Bentsen, L., Appleton, J. P., Krarup Hansen, C., …Farren, P. (2018). Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial. Lancet, 391(10123), 850-859. https://doi.org/10.1016/S0140-6736%2817%2932849-0

Background: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplat... Read More about Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial.

TICH-2 Trial – Tranexamic Acid for Intracerebral Haemorrhage 2 (2017)
Conference Proceeding
Sprigg, N., Bath, P. M., Appleton, J., Law, Z., Flaherty, K., Scutt, P., …Ali, A. (2017). TICH-2 Trial – Tranexamic Acid for Intracerebral Haemorrhage 2.

Rationale: To assess in a pragmatic phase III prospective double blind randomised placebo-controlled trial whether tranexamic acid is safe and reduces death or dependency after spontaneous intracerebral haemorrhage (SICH). The results will determine... Read More about TICH-2 Trial – Tranexamic Acid for Intracerebral Haemorrhage 2.

Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke (2017)
Journal Article
Winkel, P., Bath, P. M., Gluud, C., Lindschou, J., van der Worp, H. B., Macleod, M. R., …Schwab, S. (in press). Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke. Trials, 18(1), https://doi.org/10.1186/s13063-017-2302-z

Background: Cooling may reduce infarct size and improve neurological outcomes in patients with ischaemic stroke. In phase II trials, cooling awake patients with ischaemic stroke has been shown to be feasible and safe, but the effects in functional ou... Read More about Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke.

Relationship between race and outcome in Asian, Black and Caucasian patients with spontaneous intracerebral haemorrhage: data from the Virtual International Stroke Trials Archive (VISTA) and Efficacy of Nitric Oxide in Stroke trial (ENOS) (2017)
Journal Article
Krishnan, K., Beishon, L., Berge, E., Christensen, H., Dineen, R. A., Ozturk, S., …Bath, P. M. (2018). Relationship between race and outcome in Asian, Black and Caucasian patients with spontaneous intracerebral haemorrhage: data from the Virtual International Stroke Trials Archive (VISTA) and Efficacy of Nitric Oxide in Stroke trial (ENOS). International Journal of Stroke, 13(4), https://doi.org/10.1177/1747493017744463

Background and purpose: Although poor prognosis after intracerebral haemorrhage relates to risk factors and haematoma characteristics, there is limited evidence for the effect of race-ethnicity. Methods: Data from 1011 patients with intracerebral ha... Read More about Relationship between race and outcome in Asian, Black and Caucasian patients with spontaneous intracerebral haemorrhage: data from the Virtual International Stroke Trials Archive (VISTA) and Efficacy of Nitric Oxide in Stroke trial (ENOS).

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review (2017)
Journal Article
Armstrong, S., Langlois, A., Laparidou, D., Dixon, M., Appleton, J. P., Bath, P. M., …Siriwardena, A. N. (2017). Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review. BMC Medical Research Methodology, 17(1), Article 142. https://doi.org/10.1186/s12874-017-0423-4

Background We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods A systematic review of the literature on randomised controlled trials in ambulance setting... Read More about Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination (2017)
Journal Article
Blair, G. W., Appleton, J. P., Law, Z. K., Doubal, F., Flaherty, K., Dooley, R., …Wardlaw, J. M. (2018). Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination. International Journal of Stroke, 13(5), 530-538. https://doi.org/10.1177/1747493017731947

Rationale The pathophysiology of most lacunar stroke, a form of small vessel disease, is thought to differ from large artery atherothrombo- or cardio-embolic stroke. Licensed drugs, isosorbide mononitrate and cilostazol, have promising mechanisms... Read More about Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination.

The effect of different combinations of vascular, dependency and cognitive endpoints on the sample size required to detect a treatment effect in trials of treatments to improve outcome after lacunar and non-lacunar ischaemic stroke (2017)
Journal Article
Makin, S. D., Doubal, F., Quinn, T. J., Bath, P. M., Dennis, M. S., & Wardlaw, J. M. (in press). The effect of different combinations of vascular, dependency and cognitive endpoints on the sample size required to detect a treatment effect in trials of treatments to improve outcome after lacunar and non-lacunar ischaemic stroke. European Stroke Journal, 3(1), https://doi.org/10.1177/2396987317728854

Background Endpoints that are commonly used in trials of moderate/severe stroke may be less frequent in patients with minor, non-disabling stroke thus inflating sample sizes. We tested whether trial efficiency might be improved with composite endp... Read More about The effect of different combinations of vascular, dependency and cognitive endpoints on the sample size required to detect a treatment effect in trials of treatments to improve outcome after lacunar and non-lacunar ischaemic stroke.

Validating and comparing stroke prognosis scales (2017)
Journal Article
Quinn, T. J., Singh, S., Lees, K. R., Bath, P. M., & Myint, P. K. (2017). Validating and comparing stroke prognosis scales. Neurology, 89(10), https://doi.org/10.1212/WNL.0000000000004332

Objective: To compare the prognostic accuracy of various acute stroke prognostic scales using a large, independent, clinical trials dataset. Methods: We directly compared 8 stroke prognostic scales, chosen based on focused literature review (Acute... Read More about Validating and comparing stroke prognosis scales.

Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets (2017)
Journal Article
Hilkens, N. A., Algra, A., Diener, H., Reitsma, J. B., Bath, P. M., Csiba, L., …Greving, J. P. (2017). Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets. Neurology, 89(9), https://doi.org/10.1212/WNL.0000000000004289

Objective: To develop and externally validate a prediction model for major bleeding in patients with a TIA or ischemic stroke on antiplatelet agents. Methods: We combined individual patient data from 6 randomized clinical trials (CAPRIE, ESPS-2, M... Read More about Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets.