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Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2): safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial (2018)
Presentation / Conference Contribution
Dixon, M., Appleton, J. P., Scutt, P., England, T., Havard, D., Howard, H., Jarvis, M., Montgomery, A., Pocock, S., Potter, J., Price, C., Robinson, T., Roffe, C., Siriwardena, A. N., Sprigg, N., Wardlaw, J. M., & Bath, P. M. Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2): safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial. Presented at 4th European Stroke Organisation Conference, ESOC 2018

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., Christensen, H., Ciccone, A., Collins, R., Czlonkowska, A., Dineen, R. A., Duley, L., Egea-Guerrero, J. J., England, T. J., Krishnan, K., Laska, A. C., Law, Z. K., Ozturk, S., Pocock, S. J., Roberts, I., …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.

Results from the tranexamic acid for primary intracerebral haemorrhage-2 (TICH-2) trial (2018)
Presentation / Conference Contribution
Sprigg, N., Flaherty, K., Law, Z. K., Appleton, J. P., Scutt, P., Krishnan, K., & Bath, P. M. Results from the tranexamic acid for primary intracerebral haemorrhage-2 (TICH-2) trial. Presented at 4th European Stroke Organisation Conference ​(ESOC 2018)

Background: Haematoma expansion leads to worse outcome in intracerebral haemorrhage (ICH). Tranexamic acid (TXA) is a promising haemostatic agent to prevent haematoma expansion and improve outcome after ICH.
Methods: TICH-2 is a multicentre prospect... Read More about Results from the tranexamic acid for primary intracerebral haemorrhage-2 (TICH-2) trial.

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)
Presentation / Conference Contribution
Woodhouse, L. J., Appleton, J. P., Flaherty, K., Dineen, R. A., Sprigg, N., & Bath, P. M. 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. Presented at 4th European Stroke Organisation Conference ​(ESOC 2018)

Characteristics and outcomes of patients with or without a bleeding event: results from the triple antiplatelets for reducing dependency in ischaemic stroke (TARDIS) trial (2018)
Presentation / Conference Contribution
Woodhouse, L. J., Flaherty, K., Appleton, J. P., Sprigg, N., & Bath, P. M. Characteristics and outcomes of patients with or without a bleeding event: results from the triple antiplatelets for reducing dependency in ischaemic stroke (TARDIS) trial. Presented at 4th European Stroke Organisation Conference ​(ESOC 2018)

Background: Several studies showed that hyperglycaemia is associated with poorer prognosis in intracerebral haemorrhage. We explored the characteristics and outcomes of patients with hyperglycaemia in the Tranexamic acid in IntraCerebral Haemorrhage-... Read More about Characteristics and outcomes of patients with or without a bleeding event: results from the triple antiplatelets for reducing dependency in ischaemic stroke (TARDIS) trial.

Protocol for a prospective collaborative systematic review and meta-analysis of individual patient data from randomised controlled trials of vasoactive drugs in acute stroke: the Blood pressure in Acute Stroke Collaboration, stage-3 (BASC-3) (2018)
Journal Article
Sandset, E. C., Sanossian, N., Woodhouse, L. J., Anderson, C., Berge, E., Lees, K. R., Potter, J. F., Robinson, T. G., Sprigg, N., Wardlow, J. M., & Bath, P. M. (2018). Protocol for a prospective collaborative systematic review and meta-analysis of individual patient data from randomised controlled trials of vasoactive drugs in acute stroke: the Blood pressure in Acute Stroke Collaboration, stage-3 (BASC-3). International Journal of Stroke, 13(7), 759-765. https://doi.org/10.1177/1747493018772733

Rationale
Despite several large clinical trials assessing blood pressure lowering in acute stroke, equipoise remains, particularly for ischaemic stroke. The ‘Blood pressure in Acute Stroke Collaboration’ (BASC) commenced in the mid 1990s focusing on... Read More about Protocol for a prospective collaborative systematic review and meta-analysis of individual patient data from randomised controlled trials of vasoactive drugs in acute stroke: the Blood pressure in Acute Stroke Collaboration, stage-3 (BASC-3).

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.

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial (2018)
Journal Article
Al-Shahi Salman, R., Dennis, M. S., Murray, G. D., Innes, K., Drever, J., Dinsmore, L., Williams, C., White, P. M., Whiteley, W. N., Sandercock, P. A., Sudlow, C. L., Newby, D. E., Sprigg, N., & Werring, D. J. (2018). The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial. Trials, 19(1), Article 162. https://doi.org/10.1186/s13063-018-2542-6

Background

For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is... Read More about The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial.

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., Flaherty, K., & 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., Montgomery, A. A., Pocock, S. J., & 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., Werring, D., Al-Shahi Salman, R., England, T. J., Bath, P. M., & 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., Beridze, M., Thomsen, T. T., Christensen, H., Kruuse, C., Dineen, R. A., Jensen, H. H., Duley, L., Hansen, S. S., England, T. J., Petrovic, V., Flaherty, K., Beridze, N., Havard, D., Kakabadze, N., …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)
Presentation / Conference Contribution
Sprigg, N., Bath, P. M., Appleton, J., Law, Z., Flaherty, K., Scutt, P., Hyman-Taylor, P., Adrian, M., Stringer, M., Longmate, J., Gray, R., Gregory, H., Lysons, C., & Ali, A. TICH-2 Trial – Tranexamic Acid for Intracerebral Haemorrhage 2. Presented at 12th UK Stroke Forum Conference (UKSF 2017)

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.

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., Sprigg, N., Wardlow, J. M., & 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).

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., Shuler, K., Richardson, C., Hamilton, I., Shi, Y., Stringer, M., Boyd, J., Thrippleton, M. J., Sprigg, N., Bath, P. M., & 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 Nottingham Fatigue After Stroke (NotFAST) Study: results from follow-up six months after stroke (2017)
Journal Article
Hawkins, L., Lincoln, N., Sprigg, N., Ward, N., Mistri, A., Tyrrell, P., Worthington, E., & Drummond, A. E. (in press). The Nottingham Fatigue After Stroke (NotFAST) Study: results from follow-up six months after stroke. Topics in Stroke Rehabilitation, 24(8), https://doi.org/10.1080/10749357.2017.1368912

Background: Post-stroke fatigue is common and disabling.
Objectives: The aim of NotFAST was to examine factors associated with fatigue in stroke 3 survivors without depression, six months after stroke.
Methods: Participants were recruited from four... Read More about The Nottingham Fatigue After Stroke (NotFAST) Study: results from follow-up six months after stroke.

Route of feeding as a proxy for dysphagia after stroke and the effect of transdermal glyceryl trinitrate: data from the efficacy of nitric oxide in stroke randomised controlled trial (2017)
Journal Article
Woodhouse, L. J., Scutt, P., Hamdy, S., Smithard, D., Cohen, D. L., Roffe, C., Bereczki, D., Berge, E., Bladin, C. F., Caso, V., Christensen, H., Collins, R., Czlonkowska, A., de Silva, A., Etribi, A., Laska, A. C., Ntaios, G., Ozturk, S., Phillips, S. J., Prasad, K., …Bath, P. M. (in press). Route of feeding as a proxy for dysphagia after stroke and the effect of transdermal glyceryl trinitrate: data from the efficacy of nitric oxide in stroke randomised controlled trial. Translational Stroke Research, 9(2), https://doi.org/10.1007/s12975-017-0548-0

Post-stroke dysphagia is common, associated with poor outcome and often requires non-oral feeding/fluids. The relationship between route of feeding and outcome, as well as treatment with glyceryl trinitrate (GTN), was studied prospectively. The Effic... Read More about Route of feeding as a proxy for dysphagia after stroke and the effect of transdermal glyceryl trinitrate: data from the efficacy of nitric oxide in stroke randomised controlled trial.