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Philip M W Bath - One of the best experts on this subject based on the ideXlab platform.
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triple versus guideline Antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack the tardis rct
Health Technology Assessment, 2018Co-Authors: Philip M W Bath, Lisa J Woodhouse, Jason P Appleton, Maia Beridze, Hanne Christensen, Robert A Dineen, Katie Flaherty, Lelia DuleyAbstract:Background Two Antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents might be better still, providing it does not cause undue bleeding. Objective To compare the safety and efficacy of intensive therapy with guideline Antiplatelet therapy for acute ischaemic stroke and TIA. Design International prospective randomised open-label blinded end-point parallel-group superiority clinical trial. Setting Acute hospitals at 106 sites in four countries. Participants Patients > 50 years of age with acute non-cardioembolic ischaemic stroke or TIA within 48 hours of ictus (stroke). Interventions Participants were allocated at random by computer to 1 month of intensive (combined aspirin, clopidogrel and dipyridamole) or guideline (combined aspirin and dipyridamole, or clopidogrel alone) Antiplatelet agents, and followed for 90 days. Main outcome measures The primary outcome was the incidence and severity of any recurrent stroke (ischaemic, haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days by blinded telephone follow-up. Analysis using ordinal logistic regression was by intention to treat. Other outcomes included bleeding and its severity, death, myocardial infarction (MI), disability, mood, cognition and quality of life. Results The trial was stopped early on the recommendation of the Data Monitoring Committee after recruitment of 3096 participants (intensive, n = 1556; guideline, n = 1540) from 106 hospitals in four countries between April 2009 and March 2016. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy in 3070 (99.2%) participants with data [93 vs. 105 stroke/TIA events; adjusted common odds ratio 0.90, 95% confidence interval (CI) 0.67 to 1.20; p = 0.47]. Major (encompassing fatal) bleeding was increased with intensive as compared with guideline therapy [39 vs. 17 participants; adjusted hazard ratio (aHR) 2.23, 95% CI 1.25 to 3.96; p = 0.006]. There were no differences between the treatment groups in all-cause mortality, or the composite of death, stroke, MI and major bleeding (aHR 1.02, 95% CI 0.77 to 1.35; p = 0.88). Limitations Patients and investigators were not blinded to treatment. The comparator group comprised two guideline strategies because of changes in national guidelines during the trial. The trial was stopped early, thereby reducing its statistical power. Conclusions The use of three Antiplatelet agents is associated with increased bleeding without any significant reduction in recurrence of stroke or TIA. Future work The safety and efficacy of dual Antiplatelet therapy (combined aspirin and clopidogrel) versus aspirin remains to be defined. Further research is required on identifying individual patient response to Antiplatelets, and the relationship between response and the subsequent risks of vascular recurrent events and bleeding complications. Trial registration Current Controlled Trials ISRCTN47823388. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 48. See the NIHR Journal Library website for further project information. The Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) vanguard phase was funded by the British Heart Foundation (grant PG/08/083/25779, from 1 April 2009 to 30 September 2012) and indirect funding was provided by the Stroke Association through its funding of the Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK. There was no commercial support for the trial and Antiplatelet drugs were sourced locally at each site. The trial was sponsored by the University of Nottingham.
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dual or mono Antiplatelet therapy for patients with acute ischemic stroke or transient ischemic attack systematic review and meta analysis of randomized controlled trials
Stroke, 2012Co-Authors: Chamila Geeganage, Hanschristoph Diener, Ale Algra, Christopher P L Chen, Eric J Topol, Reinhard Dengler, Hugh S Markus, Matthew W Bath, Philip M W BathAbstract:Background and Purpose—Antiplatelets are recommended for patients with acute noncardioembolic stroke or transient ischemic attack. We compared the safety and efficacy of dual versus mono Antiplatelet therapy in patients with acute ischemic stroke or transient ischemic attack. Methods—Completed randomized controlled trials of dual versus mono Antiplatelet therapy in patients with acute (≤3 days) ischemic stroke/transient ischemic attack were identified using electronic bibliographic searches. The primary outcome was recurrent stroke (ischemic, hemorrhagic, unknown; fatal, nonfatal). Comparison of binary outcomes between treatment groups was analyzed with random effect models and described using risk ratios (95% CI). Results—Twelve completed randomized trials involving 3766 patients were included. In comparison with mono Antiplatelet therapy, dual therapy (aspirin+dipyridamole and aspirin+clopidogrel) significantly reduced stroke recurrence, dual 58 (3.3%) versus mono 91 (5.0%; risk ratio, 0.67; 95% CI, 0.4...
Lelia Duley - One of the best experts on this subject based on the ideXlab platform.
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triple versus guideline Antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack the tardis rct
Health Technology Assessment, 2018Co-Authors: Philip M W Bath, Lisa J Woodhouse, Jason P Appleton, Maia Beridze, Hanne Christensen, Robert A Dineen, Katie Flaherty, Lelia DuleyAbstract:Background Two Antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents might be better still, providing it does not cause undue bleeding. Objective To compare the safety and efficacy of intensive therapy with guideline Antiplatelet therapy for acute ischaemic stroke and TIA. Design International prospective randomised open-label blinded end-point parallel-group superiority clinical trial. Setting Acute hospitals at 106 sites in four countries. Participants Patients > 50 years of age with acute non-cardioembolic ischaemic stroke or TIA within 48 hours of ictus (stroke). Interventions Participants were allocated at random by computer to 1 month of intensive (combined aspirin, clopidogrel and dipyridamole) or guideline (combined aspirin and dipyridamole, or clopidogrel alone) Antiplatelet agents, and followed for 90 days. Main outcome measures The primary outcome was the incidence and severity of any recurrent stroke (ischaemic, haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days by blinded telephone follow-up. Analysis using ordinal logistic regression was by intention to treat. Other outcomes included bleeding and its severity, death, myocardial infarction (MI), disability, mood, cognition and quality of life. Results The trial was stopped early on the recommendation of the Data Monitoring Committee after recruitment of 3096 participants (intensive, n = 1556; guideline, n = 1540) from 106 hospitals in four countries between April 2009 and March 2016. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy in 3070 (99.2%) participants with data [93 vs. 105 stroke/TIA events; adjusted common odds ratio 0.90, 95% confidence interval (CI) 0.67 to 1.20; p = 0.47]. Major (encompassing fatal) bleeding was increased with intensive as compared with guideline therapy [39 vs. 17 participants; adjusted hazard ratio (aHR) 2.23, 95% CI 1.25 to 3.96; p = 0.006]. There were no differences between the treatment groups in all-cause mortality, or the composite of death, stroke, MI and major bleeding (aHR 1.02, 95% CI 0.77 to 1.35; p = 0.88). Limitations Patients and investigators were not blinded to treatment. The comparator group comprised two guideline strategies because of changes in national guidelines during the trial. The trial was stopped early, thereby reducing its statistical power. Conclusions The use of three Antiplatelet agents is associated with increased bleeding without any significant reduction in recurrence of stroke or TIA. Future work The safety and efficacy of dual Antiplatelet therapy (combined aspirin and clopidogrel) versus aspirin remains to be defined. Further research is required on identifying individual patient response to Antiplatelets, and the relationship between response and the subsequent risks of vascular recurrent events and bleeding complications. Trial registration Current Controlled Trials ISRCTN47823388. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 48. See the NIHR Journal Library website for further project information. The Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) vanguard phase was funded by the British Heart Foundation (grant PG/08/083/25779, from 1 April 2009 to 30 September 2012) and indirect funding was provided by the Stroke Association through its funding of the Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK. There was no commercial support for the trial and Antiplatelet drugs were sourced locally at each site. The trial was sponsored by the University of Nottingham.
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safety and efficacy of intensive vs guideline Antiplatelet therapy in high risk patients with recent ischemic stroke or transient ischemic attack rationale and design of the triple Antiplatelets for reducing dependency after ischaemic stroke tardis t
International Journal of Stroke, 2015Co-Authors: Kailash Krishnan, Hugh S Markus, Maia Beridze, Hanne Christensen, Robert A Dineen, Lelia Duley, S Heptinstall, Marilyn James, Stuart J Pocock, Annemarei RantaAbstract:RATIONALE: The risk of recurrence following a stroke or transient ischemic attack is high, especially immediately after the event. HYPOTHESIS: Because two Antiplatelet agents are superior to one in patients with non-cardioembolic events, more intensive treatment might be even more effective. SAMPLE SIZE ESTIMATES: The sample size of 4100 patients will allow a shift to less recurrence, and less severe recurrence, to be detected (odds ratio 0·68) with 90% power at 5% significance. METHODS AND DESIGN: Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (ISRCTN47823388) is comparing the safety and efficacy of intensive (combined aspirin, clopidogrel, and dipyridamole) vs. guideline Antiplatelet therapy, both given for one-month. This international collaborative parallel-group prospective randomized open-label blinded-end-point phase III trial plans to recruit 4100 patients with acute ischemic stroke or transient ischemic attack. Randomization and data collection are performed over a secure Internet site with real-time data validation and concealment of allocation. Outcomes, serious adverse events, and neuroimaging are adjudicated centrally with blinding to treatment allocation. STUDY OUTCOME: The primary outcome is stroke recurrence and its severity ('ordinal recurrence' based on modified Rankin Scale) at 90 days, with masked assessment centrally by telephone. Secondary outcomes include vascular events, functional measures (disability, mood, cognition, quality of life), and safety (bleeding, death, serious adverse events). DISCUSSION: The trial has recruited more than 50% of its target sample size (latest number: 2399) and is running in 104 sites in 4 countries. One-third of patients presented with a transient ischemic attack.
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Antiplatelet agents for preventing pre eclampsia and its complications
Cochrane Database of Systematic Reviews, 2007Co-Authors: Lelia Duley, David J Hendersonsmart, Shireen Meher, James F KingAbstract:Background Pre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that Antiplatelet agents, low-dose aspirin in particular, might prevent or delay development of pre-eclampsia. Objectives To assess the effectiveness and safety of Antiplatelet agents for women at risk of developing pre-eclampsia. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 1), EMBASE (1994 to November 2005) and handsearched congress proceedings of the International and European Societies for the Study of Hypertension in Pregnancy. We updated the search of the Cochrane Pregnancy and Childbirth Group's Trials Register on 31 May 2010 and added the results to the awaiting classification section Selection criteria All randomised trials comparing Antiplatelet agents with either placebo or no Antiplatelet agent were included. Quasi-random studies were excluded. Participants were pregnant women at risk of developing pre-eclampsia. Interventions were any comparisons of an Antiplatelet agent (such as low-dose aspirin or dipyridamole) with either placebo or no Antiplatelet. Data collection and analysis Two authors assessed trials for inclusion and extracted data independently. Main results Fifty-nine trials (37,560 women) are included. There is a 17% reduction in the risk of pre-eclampsia associated with the use of Antiplatelet agents ((46 trials, 32,891 women, relative risk (RR) 0.83, 95% confidence interval (CI) 0.77 to 0.89), number needed to treat (NNT) 72 (52, 119)). Although there is no statistical difference in RR based on maternal risk, there is a significant increase in the absolute risk reduction of pre-eclampsia for high risk (risk difference (RD) -5.2% (-7.5, -2.9), NNT 19 (13, 34)) compared with moderate risk women (RD -0.84 (-1.37, -0.3), NNT 119 (73, 333)). Antiplatelets were associated with an 8% reduction in the relative risk of preterm birth (29 trials, 31,151 women, RR 0.92, 95% CI 0.88 to 0.97); NNT 72 (52, 119)), a 14% reduction in fetal or neonatal deaths (40 trials, 33,098 women, RR 0.86, 95% CI 0.76 to 0.98); NNT 243 (131, 1,666) and a 10% reduction in small-for-gestational age babies (36 trials, 23,638 women, RR 0.90, 95% CI0.83 to 0.98). There were no statistically significant differences between treatment and control groups for any other outcomes. Authors' conclusions Antiplatelet agents, largely low-dose aspirin, have moderate benefits when used for prevention of pre-eclampsia and its consequences. Further information is required to assess which women are most likely to benefit, when treatment is best started, and at what dose. [Note: The 16 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]
Hanschristoph Diener - One of the best experts on this subject based on the ideXlab platform.
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treatment of acute ischaemic stroke with thrombolysis or thrombectomy in patients receiving anti thrombotic treatment
Lancet Neurology, 2013Co-Authors: Hanschristoph Diener, Christian Foerch, Hanno Riess, Joachim Rother, Gerhard Schroth, Ralph WeberAbstract:Summary Systemic thrombolysis with alteplase is the only approved medical treatment for patients with acute ischaemic stroke. Thrombectomy is also increasingly used to treat proximal occlusions of the cerebral arteries, but has not shown superiority over systemic thrombolysis with alteplase. Many patients with acute ischaemic stroke are pretreated with Antiplatelet or anticoagulant drugs, which can increase the bleeding risk of thrombolysis or thrombectomy. Pretreatment with aspirin monotherapy increases the bleeding risk of alteplase in both observational and randomised trials with no effect on clinical outcome, and the risk of intracerebral haemorrhage is increased with the combination of aspirin and clopidogrel. Antiplatelet drugs should not be given in the first 24 h after alteplase treatment. Data from pooled randomised trials and a large observational study show that thrombolysis can probably be done safely in patients given vitamin-K antagonists if the international normalised ratio is less than 1·7, although bleeding risk is slightly raised. Almost no data are available for the safety of alteplase in patients with atrial fibrillation who have been given novel oral anticoagulants (NOAC) for stroke prevention. Some coagulation parameters could help to identify patients treated with NOAC who might be eligible for thrombolysis. Thrombectomy can be done in patients given Antiplatelets and probably in those given anticoagulants; however, conclusions about anticoagulants are based on findings from observational studies with small patient numbers.
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dual or mono Antiplatelet therapy for patients with acute ischemic stroke or transient ischemic attack systematic review and meta analysis of randomized controlled trials
Stroke, 2012Co-Authors: Chamila Geeganage, Hanschristoph Diener, Ale Algra, Christopher P L Chen, Eric J Topol, Reinhard Dengler, Hugh S Markus, Matthew W Bath, Philip M W BathAbstract:Background and Purpose—Antiplatelets are recommended for patients with acute noncardioembolic stroke or transient ischemic attack. We compared the safety and efficacy of dual versus mono Antiplatelet therapy in patients with acute ischemic stroke or transient ischemic attack. Methods—Completed randomized controlled trials of dual versus mono Antiplatelet therapy in patients with acute (≤3 days) ischemic stroke/transient ischemic attack were identified using electronic bibliographic searches. The primary outcome was recurrent stroke (ischemic, hemorrhagic, unknown; fatal, nonfatal). Comparison of binary outcomes between treatment groups was analyzed with random effect models and described using risk ratios (95% CI). Results—Twelve completed randomized trials involving 3766 patients were included. In comparison with mono Antiplatelet therapy, dual therapy (aspirin+dipyridamole and aspirin+clopidogrel) significantly reduced stroke recurrence, dual 58 (3.3%) versus mono 91 (5.0%; risk ratio, 0.67; 95% CI, 0.4...
Jayna Holroydleduc - One of the best experts on this subject based on the ideXlab platform.
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anticoagulant and Antiplatelet use in seniors with chronic subdural hematoma systematic review
Neurology, 2017Co-Authors: Santhosh Nathan, Zahra Goodarzi, Nathalie Jette, Clare N Gallagher, Jayna HolroydleducAbstract:Objective: To address whether to restart older patients on anticoagulants or Antiplatelet agents in the setting of a chronic subdural hematoma (cSDH). Methods: This is an update of a previous review (searched until July 2012). Medline, EMBASE, ISI Web of Knowledge, Google Scholar, PLOS, and the Cochrane Register for Systematic Reviews databases were searched from January 2012 to December 2016. Studies included older adults (those over 65 years) experiencing traumatic subdural hematoma or cSDH who were on anticoagulation or Antiplatelet agents. Results: Seven studies were included (mean age 72 years). Four out of 7 studies provided combined data on anticoagulants or Antiplatelet use. Only one study found anticoagulant or Antiplatelet agent use to be a significant factor for cSDH rebleeding. Two studies considered anticoagulant use only and both reported similar increased odds of rebleeding (odds ratio [OR] 1.75, 95% confidence interval [CI] 0.18–16.86; OR 2.7 95% CI 1.42–6.96). Antiplatelets were not found to be associated with rebleeding. Ideal timing to resume anticoagulants or Antiplatelets was unclear. Conclusions: Anticoagulant medication was associated with increased rebleeding risk in older adults with cSDH. However, Antiplatelet medication was not associated with increased risk of rebleeding.
Santhosh Nathan - One of the best experts on this subject based on the ideXlab platform.
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anticoagulant and Antiplatelet use in seniors with chronic subdural hematoma systematic review
Neurology, 2017Co-Authors: Santhosh Nathan, Zahra Goodarzi, Nathalie Jette, Clare N Gallagher, Jayna HolroydleducAbstract:Objective: To address whether to restart older patients on anticoagulants or Antiplatelet agents in the setting of a chronic subdural hematoma (cSDH). Methods: This is an update of a previous review (searched until July 2012). Medline, EMBASE, ISI Web of Knowledge, Google Scholar, PLOS, and the Cochrane Register for Systematic Reviews databases were searched from January 2012 to December 2016. Studies included older adults (those over 65 years) experiencing traumatic subdural hematoma or cSDH who were on anticoagulation or Antiplatelet agents. Results: Seven studies were included (mean age 72 years). Four out of 7 studies provided combined data on anticoagulants or Antiplatelet use. Only one study found anticoagulant or Antiplatelet agent use to be a significant factor for cSDH rebleeding. Two studies considered anticoagulant use only and both reported similar increased odds of rebleeding (odds ratio [OR] 1.75, 95% confidence interval [CI] 0.18–16.86; OR 2.7 95% CI 1.42–6.96). Antiplatelets were not found to be associated with rebleeding. Ideal timing to resume anticoagulants or Antiplatelets was unclear. Conclusions: Anticoagulant medication was associated with increased rebleeding risk in older adults with cSDH. However, Antiplatelet medication was not associated with increased risk of rebleeding.
