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Design of trials in lacunar stroke and cerebral small vessel disease: Review and experience with the LACunar Intervention Trial 2 (LACI-2) (2024)
Journal Article
Blair, G., Appleton, J. P., Doubal, F. N., Mhlanga, I. I., Woodhouse, L. J., Bath, P. M., & Wardlaw, J. (in press). Design of trials in lacunar stroke and cerebral small vessel disease: Review and experience with the LACunar Intervention Trial 2 (LACI-2). Stroke and Vascular Neurology,

Background: Cerebral small vessel disease (cSVD) causes lacunar stroke (25% of ischaemic strokes), haemorrhage, dementia, physical frailty, or is ‘covert’, but has no specific treatment. Uncertainties about the design of clinical trials in cSVD, whic... Read More about Design of trials in lacunar stroke and cerebral small vessel disease: Review and experience with the LACunar Intervention Trial 2 (LACI-2).

Influence of time to achieve target systolic blood pressure on outcome after intracerebral hemorrhage: the Blood Pressure in Acute Stroke Collaboration (2024)
Journal Article
Wang, X., Yang, J., Moullaali, T. J., Sandset, E. C., Woodhouse, L. J., Law, Z. K., …Chalmers, J. (2024). Influence of time to achieve target systolic blood pressure on outcome after intracerebral hemorrhage: the Blood Pressure in Acute Stroke Collaboration. Stroke, https://doi.org/10.1161/strokeaha.123.044358

OBJECTIVE: To investigate whether an earlier time to achieving and maintaining systolic blood pressure (SBP) at 120 to 140 mm Hg is associated with favorable outcomes in a cohort of patients with acute intracerebral hemorrhage. METHODS: We pooled ind... Read More about Influence of time to achieve target systolic blood pressure on outcome after intracerebral hemorrhage: the Blood Pressure in Acute Stroke Collaboration.

Prevention of infections and fever to improve outcome in older patients with acute stroke (PRECIOUS): a randomised, open, phase III, multifactorial, clinical trial with blinded outcome assessment (2023)
Journal Article
de Jonge, J. C., Sluis, W. M., Reinink, H., Bath, P. M., Woodhouse, L. J., Zweedijk, B., …van der Worp, H. B. (2024). Prevention of infections and fever to improve outcome in older patients with acute stroke (PRECIOUS): a randomised, open, phase III, multifactorial, clinical trial with blinded outcome assessment. Lancet Regional Health – Europe, 36, Article 100782. https://doi.org/10.1016/j.lanepe.2023.100782

Background Infections and fever after stroke are associated with poor functional outcome or death. We assessed whether prophylactic treatment with anti-emetic, antibiotic, or antipyretic medication would improve functional outcome in older patient... Read More about Prevention of infections and fever to improve outcome in older patients with acute stroke (PRECIOUS): a randomised, open, phase III, multifactorial, clinical trial with blinded outcome assessment.

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.

Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure (2023)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Pocock, S., James, M., Ranta, A., Bath, P. M., & TARDIS Investigators, T. I. (2023). Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure. Contemporary Clinical Trials Communications, 35, Article 101186. https://doi.org/10.1016/j.conctc.2023.101186

Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its p... Read More about Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure.

Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): effects on outcomes at day 365 in a randomised, sham-controlled, blinded, phase III, superiority ambulance-based trial (2023)
Journal Article
Woodhouse, L. J., Appleton, J. P., Ankolekar, S., England, T. J., Mair, G., Muir, K., …Bath, P. M. (2023). Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): effects on outcomes at day 365 in a randomised, sham-controlled, blinded, phase III, superiority ambulance-based trial. BMJ Neurology Open, 5(1), Article e000424. https://doi.org/10.1136/bmjno-2023-000424

Background The Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial-2 (RIGHT-2) reported no overall treatment difference between glyceryl trinitrate (GTN) and sham at day 90. Here we assess participants' outcomes 1 year after rand... Read More about Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): effects on outcomes at day 365 in a randomised, sham-controlled, blinded, phase III, superiority ambulance-based trial.

Desmopressin for patients with spontaneous intracerebral haemorrhage taking antiplatelet drugs (DASH): a UK-based, phase 2, randomised, placebo-controlled, multicentre feasibility trial (2023)
Journal Article
Desborough, M. J. R., Al-Shahi Salman, R., Stanworth, S. J., Havard, D., Woodhouse, L. J., Craig, J., …for DASH trial investigators, F. D. T. I. (2023). Desmopressin for patients with spontaneous intracerebral haemorrhage taking antiplatelet drugs (DASH): a UK-based, phase 2, randomised, placebo-controlled, multicentre feasibility trial. Lancet Neurology, 22(7), 557-567. https://doi.org/10.1016/S1474-4422%2823%2900157-6

Background: The risk of death from spontaneous intracerebral haemorrhage is increased for people taking antiplatelet drugs. We aimed to assess the feasibility of randomising patients on antiplatelet drug therapy with spontaneous intracerebral haemorr... Read More about Desmopressin for patients with spontaneous intracerebral haemorrhage taking antiplatelet drugs (DASH): a UK-based, phase 2, randomised, placebo-controlled, multicentre feasibility trial.

Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: A secondary analysis of a large randomised controlled trial (2023)
Journal Article
Appleton, J. P., Kang, Z., Woodhouse, L. J., Al-Shahi Salman, R., Beridze, M., Christensen, H., …Sprigg, N. (2023). Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: A secondary analysis of a large randomised controlled trial. BMJ Neurology Open, 5(1), Article e000423. https://doi.org/10.1136/bmjno-2023-000423

Background Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statist... Read More about Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: A secondary analysis of a large randomised controlled trial.

Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial (2023)
Journal Article
Appleton, J. P., Woodhouse, L. J., Anderson, C. S., Ankolekar, S., Cala, L., Dixon, M., …Bath, P. M. (2023). Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial. Stroke and Vascular Neurology, 9(1), https://doi.org/10.1136/svn-2022-001634

Background The effect of transdermal glyceryl trinitrate (GTN, a nitrovasodilator) on clinical outcome when administered before hospital admission in suspected stroke patients is unclear. Here, we assess the safety and efficacy of GTN in the prespeci... Read More about Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial.

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.

Time intervals and distances travelled for prehospital ambulance stroke care: data from the randomised-controlled ambulance-based Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) (2022)
Journal Article
Dixon, M., Appleton, J. P., Scutt, P., Woodhouse, L. J., Haywood, L. J., Havard, D., …Bath, P. M. (2022). Time intervals and distances travelled for prehospital ambulance stroke care: data from the randomised-controlled ambulance-based Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2). BMJ Open, 12(11), Article e060211. https://doi.org/10.1136/bmjopen-2021-060211

Objectives Ambulances offer the first opportunity to evaluate hyperacute stroke treatments. We investigated the conduct of a hyperacute stroke study in the ambulance-based setting with a particular focus on timings and logistics of trial delivery.... Read More about Time intervals and distances travelled for prehospital ambulance stroke care: data from the randomised-controlled ambulance-based Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2).

Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial (2022)
Journal Article
Bath, P. M., Skinner, C. J. C., Bath, C. S., Woodhouse, L. J., Areti, A., Korovesi, K., …Gordon, A. L. (2022). Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial. European Geriatric Medicine, 13, 1343-1355. https://doi.org/10.1007/s41999-022-00714-5

Purpose Infections cause considerable care home morbidity and mortality. Nitric oxide (NO) has broad-spectrum anti-viral, bacterial and yeast activity in vitro. We assessed the feasibility of supplementing dietary nitrate (NO substrate) intake in ca... Read More about Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial.

Measures of intracranial compartments in acute intracerebral haemorrhage: data from the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke-2 Trial (RIGHT-2) (2022)
Journal Article
Krishnan, K., Law, Z. K., Woodhouse, L. J., Dineen, R. A., Sprigg, N., Wardlaw, J. M., & Bath, P. M. (2023). Measures of intracranial compartments in acute intracerebral haemorrhage: data from the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke-2 Trial (RIGHT-2). Stroke and Vascular Neurology, 8(2), 151-160. https://doi.org/10.1136/svn-2021-001375

Background and purpose: Intracerebral haemorrhage volume (ICHV) is prognostically important but does not account for intracranial volume (ICV) and cerebral parenchymal volume (CPV). We assessed measures of intracranial compartments in acute ICH using... Read More about Measures of intracranial compartments in acute intracerebral haemorrhage: data from the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke-2 Trial (RIGHT-2).

Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850) (2022)
Journal Article
Bath, P. M., Mhlanga, I., Woodhouse, L. J., Doubal, F., Oatey, K., Montgomery, A. A., … LACI-2 Trial Investigators. (2023). Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850). Stroke and Vascular Neurology, 8, Article e001816. https://doi.org/10.1136/svn-2022-001816

Background: Cerebral small vessel disease (SVD) causes lacunar strokes (25% of all ischaemic strokes), physical frailty and cognitive impairment and vascular and mixed dementia. There is no specific treatment to prevent progression of SVD. Methods: T... Read More about Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850).

Effect of Tranexamic Acid Administration on Remote Cerebral Ischemic Lesions in Acute Spontaneous Intracerebral Hemorrhage: A Substudy of a Randomized Clinical Trial (2022)
Journal Article
Pszczolkowski, S., Sprigg, N., Woodhouse, L. J., Gallagher, R., Swienton, D., Law, Z. K., …Dineen, R. A. (2022). Effect of Tranexamic Acid Administration on Remote Cerebral Ischemic Lesions in Acute Spontaneous Intracerebral Hemorrhage: A Substudy of a Randomized Clinical Trial. JAMA Neurology, 79(5), 468-477. https://doi.org/10.1001/jamaneurol.2022.0217

Importance: Hyperintense foci on diffusion-weighted imaging (DWI) that are spatially remote from the acute hematoma occur in 20% of people with acute spontaneous intracerebral hemorrhage (ICH). Tranexamic acid, a hemostatic agent that is under invest... Read More about Effect of Tranexamic Acid Administration on Remote Cerebral Ischemic Lesions in Acute Spontaneous Intracerebral Hemorrhage: A Substudy of a Randomized Clinical Trial.

Effect of continuing versus stopping pre-stroke antihypertensive agents within 12h on outcome after stroke: A subgroup analysis of the efficacy of nitric oxide in stroke (ENOS) trial (2022)
Journal Article
Woodhouse, L. J., Appleton, J. P., Scutt, P., Everton, L., Wilkinson, G., Caso, V., …Bath, P. M. (2022). Effect of continuing versus stopping pre-stroke antihypertensive agents within 12h on outcome after stroke: A subgroup analysis of the efficacy of nitric oxide in stroke (ENOS) trial. eClinicalMedicine, 44, Article 101274. https://doi.org/10.1016/j.eclinm.2022.101274

Background: It is not known whether to continue or temporarily stop existing antihypertensive drugs in patients with acute stroke. Methods: We performed a prospective subgroup analysis of patients enrolled into the Efficacy of Nitric Oxide in Stroke... Read More about Effect of continuing versus stopping pre-stroke antihypertensive agents within 12h on outcome after stroke: A subgroup analysis of the efficacy of nitric oxide in stroke (ENOS) trial.

Pre-hospital transdermal glyceryl trinitrate in patients with stroke mimics: data from the RIGHT-2 randomised-controlled ambulance trial (2022)
Journal Article
Tunnage, B., Woodhouse, L. J., Dixon, M., Anderson, C. S., Ankolekar, S., Appleton, J. P., …Bath, P. M. (2022). Pre-hospital transdermal glyceryl trinitrate in patients with stroke mimics: data from the RIGHT-2 randomised-controlled ambulance trial. BMC Emergency Medicine, 22(1), Article 2. https://doi.org/10.1186/s12873-021-00560-x

Background: Prehospital stroke trials will inevitably recruit patients with non-stroke conditions, so called stroke mimics. We undertook a pre-specified analysis to determine outcomes in patients with mimics in the second Rapid Intervention with Glyc... Read More about Pre-hospital transdermal glyceryl trinitrate in patients with stroke mimics: data from the RIGHT-2 randomised-controlled ambulance 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.

Corrigendum: Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis (2020)
Journal Article
Appleton, J. P., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., & Bath, P. M. (2020). Corrigendum: Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis. Frontiers in Neurology, 11, Article 625572. https://doi.org/10.3389/fneur.2020.625572

Joanna M. Wardlaw was not included as an author in the published article. The corrected Author Contributions and Funding statements appear below. AUTHOR CONTRIBUTIONS JA performed the literature search, pooled analyses, statistical analysis and inter... Read More about Corrigendum: Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis.

Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial (2020)
Journal Article
Beishon, L., Woodhouse, L. J., Bereczki, D., Christensen, H. K., Collins, R., Gommans, J., …Bath, P. M. (2021). Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial. Stroke and Vascular Neurology, 6(2), 180-186. https://doi.org/10.1136/svn-2020-000498

Introduction Nitrate-induced headache is common and may signify responsive cerebral vasculature. We assessed the relationship between nitrate headache and outcome in patients with acute stroke. Materials and methods Patients were those randomised to... Read More about Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial.