All Outputs (21)

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.

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.

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., …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., 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).

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.-C., 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.

Infections up to 76 days after stroke increase disability and death (2017)
Journal Article
Learoyd, A., Woodhouse, L. J., Shaw, L., Sprigg, N., Bereczki, D., Berge, E., …Trueman, R. C. (in press). Infections up to 76 days after stroke increase disability and death. Translational Stroke Research, https://doi.org/10.1007/s12975-017-0553-3

Early infection after stroke is associated with a poor outcome. We aimed to determine whether delayed infections (up to 76 days post-stroke) are associated with poor outcome at 90 days. Data came from the international Efficacy of Nitric Oxide Stroke... Read More about Infections up to 76 days after stroke increase disability and death.

Remote assessment of platelet function in patients with acute stroke or transient ischaemic attack (2017)
Journal Article
Bath, P. M., May, J., Flaherty, K., Woodhouse, L. J., Dovlatova, N., Fox, S. C., England, T. J., Krishnan, K., Robinson, T. G., Sprigg, N., Heptinstall, S., & TARDIS Investigators. (2017). Remote assessment of platelet function in patients with acute stroke or transient ischaemic attack. Stroke Research and Treatment, 2017, Article 7365684. https://doi.org/10.1155/2017/7365684

Background: Antiplatelets reduce recurrence after cerebral ischaemia. The international TARDIS trial assessed the safety and efficacy of intensive (combined aspirin, dipyridamole and clopidogrel) versus guideline (aspirin and dipyridamole, or clopido... Read More about Remote assessment of platelet function in patients with acute stroke or transient ischaemic attack.

Cerebral misery perfusion due to carotid occlusive disease (2017)
Journal Article
Maddula, M., Sprigg, N., Bath, P. M., & Munshi, S. K. (in press). Cerebral misery perfusion due to carotid occlusive disease. Stroke and Vascular Neurology, Article e000067. https://doi.org/10.1136/svn-2017-000067

Purpose Cerebral misery perfusion (CMP) is a condition where cerebral autoregulatory capacity is exhausted, and cerebral blood supply in insufficient to meet metabolic demand. We present an educational review of this important condition, which has a... Read More about Cerebral misery perfusion due to carotid occlusive disease.

The incidence of first stroke in and around pregnancy: A population-based cohort study from Sweden (2017)
Journal Article
Ban, L., Abdul Sultan, A., Stephansson, O., Tata, L. J., Sprigg, N., Nelson-Piercy, C., …Ludvigsson, J. F. (2017). The incidence of first stroke in and around pregnancy: A population-based cohort study from Sweden. European Stroke Journal, 2(3), 250-256. https://doi.org/10.1177/2396987317706600

Introduction:
Research has suggested that delivery is associated with an increased risk of stroke in women; however, there is a lack of contemporary estimates on the incidence of stroke in and after pregnancy compared with the baseline risk in women... Read More about The incidence of first stroke in and around pregnancy: A population-based cohort study from Sweden.

The incidence of first stroke in pregnant and non-pregnant women of childbearing age: a population-based cohort study from England (2017)
Journal Article
Ban, L., Sprigg, N., Nelson-Piercy, C., Bath, P. M., Ludvigsson, J. F., Stephansson, O., & Tata, L. J. (2017). The incidence of first stroke in pregnant and non-pregnant women of childbearing age: a population-based cohort study from England. Journal of the American Heart Association, 6(4), Article e004601. https://doi.org/10.1161/JAHA.116.004601

Background: Pregnant women may have an increased risk of stroke compared to non-pregnant women of similar age, but the magnitude and the timing of such risk are unclear. We examined the risk of first stroke event in women of childbearing age and comp... Read More about The incidence of first stroke in pregnant and non-pregnant women of childbearing age: a population-based cohort study from England.

Nitric oxide donors (nitrates), L-arginine, or nitric oxide synthase inhibitors for acute stroke (2017)
Journal Article
Bath, P. M., Krishnan, K., & Appleton, J. P. (in press). Nitric oxide donors (nitrates), L-arginine, or nitric oxide synthase inhibitors for acute stroke. Cochrane Database of Systematic Reviews, Article CD000398. https://doi.org/10.1002/14651858.CD000398.pub2

Background:Nitric oxide (NO) has multiple effects that may be beneficial in acute stroke, including lowering blood pressure, and promoting reperfusion and cytoprotection. Some forms of nitric oxide synthase inhibition (NOS-I) may also be beneficial.... Read More about Nitric oxide donors (nitrates), L-arginine, or nitric oxide synthase inhibitors for acute stroke.

Interruption to antiplatelet therapy early after acute ischaemic stroke: a nested case-control study (2017)
Journal Article
Mazlan-Kepli, W., Macisaac, R. L., Walters, M., Bath, P. M. W., & Dawson, J. (2017). Interruption to antiplatelet therapy early after acute ischaemic stroke: a nested case-control study. British Journal of Clinical Pharmacology, 83(9), https://doi.org/10.1111/bcp.13290

Aims: Antiplatelet drugs are often discontinued early after ischaemic stroke, either because of poor compliance, complications or withdrawal of care. It is unclear whether this places patients at increased risk of recurrence. We explored the associat... Read More about Interruption to antiplatelet therapy early after acute ischaemic stroke: a nested case-control study.

Remote Ischaemic Conditioning after Stroke Trial (RECAST): a pilot randomised placebo controlled phase II trial in acute ischaemic stroke (ISRCTN 86672015) (2017)
Journal Article
England, T. J., Hedstrom, A., O'Sullivan, S., Donnelly, R., Barrett, D. A., Sarmad, S., Sprigg, N., & Bath, P. M. (2017). Remote Ischaemic Conditioning after Stroke Trial (RECAST): a pilot randomised placebo controlled phase II trial in acute ischaemic stroke (ISRCTN 86672015). Stroke, 48(5), https://doi.org/10.1161/STROKEAHA.116.016429

Background:
Repeated episodes of limb ischaemia and reperfusion (remote ischaemic conditioning, RIC) may improve outcome after acute stroke.
Methods:
We performed a pilot blinded placebo-controlled trial in patients with acute ischaemic stroke, ra... Read More about Remote Ischaemic Conditioning after Stroke Trial (RECAST): a pilot randomised placebo controlled phase II trial in acute ischaemic stroke (ISRCTN 86672015).

Magnetic resonance imaging plaque hemorrhage for risk stratification in carotid artery disease with moderate risk under current medical therapy (2017)
Journal Article
Hosseini, A. A., Simpson, R. J., Altaf, N., Bath, P. M., MacSweeney, S. T., & Auer, D. P. (2017). Magnetic resonance imaging plaque hemorrhage for risk stratification in carotid artery disease with moderate risk under current medical therapy. Stroke, 48(3), https://doi.org/10.1161/STROKEAHA.116.015504

Background and Purpose—Magnetic resonance imaging (MRI)–defined carotid plaque hemorrhage (MRIPH) can predict recurrent cerebrovascular ischemic events in severe symptomatic carotid stenosis. It is less clear whether MRIPH can improve risk stratifica... Read More about Magnetic resonance imaging plaque hemorrhage for risk stratification in carotid artery disease with moderate risk under current medical therapy.

Investigating the effect of independent blinded digital image assessment on the STOP GAP trial (2017)
Journal Article
Patsko, E., Godolphin, P. J., Thomas, K. S., Hepburn, T., Mitchell, E., Craig, F. E., …Montgomery, A. A. (2017). Investigating the effect of independent blinded digital image assessment on the STOP GAP trial. Trials, 18(1), Article 53. https://doi.org/10.1186/s13063-017-1779-9

Background
Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low risk studies. In dermatology, one popu... Read More about Investigating the effect of independent blinded digital image assessment on the STOP GAP trial.