All Outputs (14)

Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia (2023)
Journal Article
Woodhouse, L. J., Appleton, J. P., Christensen, H., Dineen, R. A., England, T. J., James, M., …Bath, P. M. (2023). Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia. Scientific Reports, 13, Article 11717. https://doi.org/10.1038/s41598-023-38474-2

Intensive antiplatelet therapy did not reduce recurrent stroke/transient ischaemic attack (TIA) events as compared with guideline treatment in the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial, but did increase th... Read More about Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia.

Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial (2023)
Journal Article
Wardlaw, J. M., Woodhouse, L. J., Mhlanga, I. I., Oatey, K., Heye, A. K., Bamford, J., …Bath, P. M. (2023). Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial. JAMA Neurology, 80(7), 682-692. https://doi.org/10.1001/jamaneurol.2023.1526

Importance Cerebral small vessel disease (cSVD) is a common cause of stroke (lacunar stroke), is the most common cause of vascular cognitive impairment, and impairs mobility and mood but has no specific treatment. Objective To test the feasibili... Read More about Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial.

Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial (2021)
Journal Article
the TICH-2 Investigators, Law, Z. K., Appleton, J. P., Scutt, P., Roberts, I., Al-Shahi Salman, R., …Sprigg, N. (2021). Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial. Stroke, 53(4), 1141-1148. https://doi.org/10.1161/STROKEAHA.121.035191

Background: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) rand... Read More about Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial.

Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials (2021)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Mant, J., Davis, B. R., Algra, A., Mas, J., …Bath, P. M. (2021). Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials. BMC Medical Research Methodology, 21, Article 218. https://doi.org/10.1186/s12874-021-01388-6

Background: Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best ana... Read More about Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials.

Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage (2021)
Journal Article
Pszczolkowski, S., Manzano-Patron, J. P., Law, Z. K., Krishnan, K., Ali, A., Bath, P. M., …Dineen, R. A. (2021). Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage. European Radiology, 31, 7945-7959. https://doi.org/10.1007/s00330-021-07826-9

Objectives To test radiomics-based features extracted from noncontrast CT of patients with spontaneous intracerebral haemorrhage for prediction of haematoma expansion and poor functional outcome and compare them with radiological signs and clinica... Read More about Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage.

Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial (2020)
Journal Article
Desborough, M. J., Al-Shahi Salman, R., Stanworth, S. J., Havard, D., Brennan, P. M., Dineen, R. A., …DASH trial investigators. (2020). Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial. BMJ Open, 10(11), Article e037555. https://doi.org/10.1136/bmjopen-2020-037555

Introduction Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not usin... Read More about Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial.

Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage (2019)
Journal Article
Bath, P. M., Woodhouse, L. J., Krishnan, K., Appleton, J. P., Anderson, C. S., Berge, E., …Sprigg, N. (2019). Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage. Stroke, 50(11), 3064-3071. https://doi.org/10.1161/STROKEAHA.119.026389

Background and Purpose— Pilot trials suggest that glyceryl trinitrate (GTN; nitroglycerin) may improve outcome when administered early after stroke onset. Methods— We undertook a multicentre, paramedic-delivered, ambulance-based, prospective ran... Read More about Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage.

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis (2019)
Journal Article
Godolphin, P. J., Bath, P. M., Algra, A., Berge, E., Brown, M. M., Chalmers, J., …on behalf of the Adjudicating Outcomes in Stroke Trials Collaboration*. (2019). Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis. Stroke, 50(8), 2187-2196. https://doi.org/10.1161/strokeaha.119.025019

© 2019 American Heart Association, Inc. Background and Purpose-In randomized stroke trials, central adjudication of a trial's primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in rando... Read More about Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis.

Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation (2018)
Journal Article
Godolphin, P., Hepburn, T., Sprigg, N., Walker, L., Berge, E., Collins, R., …Montgomery, A. (2018). Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation. Contemporary Clinical Trials Communications, 12, 176-181. https://doi.org/10.1016/j.conctc.2018.11.002

Background Central adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (E... Read More about Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation.

Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial (2018)
Journal Article
Sprigg, N., Flaherty, K., Appleton, J. P., Al-Shahi Salman, R., Bereczki, D., Beridze, M., …Bath, P. M. (2018). Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial. Lancet, 391(10135), 2107-2115. https://doi.org/10.1016/S0140-6736%2818%2931033-X

Background Tranexamic acid (TXA) reduces death due to bleeding after trauma and post-partum haemorrhage. The aim was to assess if tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral 6 haemorrha... Read More about Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial.

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)’.

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.

Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053) (2017)
Journal Article
Appleton, J. P., Scutt, P., Dixon, M., Howard, H., Haywood, L., Havard, D., …Bath, P. M. (in press). Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053). International Journal of Stroke, https://doi.org/10.1177/1747493017724627

Rationale: Vascular nitric oxide levels are low in acute stroke and donors such as glyceryl trinitrate have shown promise when administered very early after stroke. Potential mechanisms of action include augmentation of cerebral reperfusion, thrombol... Read More about Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053).

Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial (2016)
Journal Article
Bath, P. M., Appleton, J. P., Beridze, M., Christensen, H., Dineen, R. A., Duley, L., …Sprigg, N. (2017). Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial. International Journal of Stroke, 12(5), 524-538. https://doi.org/10.1177/1747493016677988

Background: The risk of recurrence following ischaemic stroke (IS) or transient ischaemic attack (TIA) is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in... Read More about Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial.