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Sex differences in the clinical and surgical management after intracerebral hemorrhage: A post hoc analysis of the INTERACT3 clinical trial
(SAGE Publications, 2026-02-05)
Ma. Ignacia Allende
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Cheryl Carcel
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MUÑOZ VENTURELLI, PAULA ANDREA
;
Katie Harris
;
Menglu Ouyang
<jats:sec> <jats:title>Introduction:</jats:title> <jats:p>As the management of intracerebral hemorrhage (ICH) shifts from historical inertia to more proactive, evidence-based care, ensuring sex-equitable access to best-practice stroke care is increasingly important. Data on sex differences in access to care for ICH remains limited and often conflicting. More robust evidence is required to understand where disparities may exist to inform targeted interventions.</jats:p> </jats:sec> <jats:sec> <jats:title>Aims:</jats:title> <jats:p>We aimed to determine sex differences in the clinical and surgical management of patients with acute ICH who participated in the third Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>We performed a post hoc analysis of INTERACT3, an international stepped-wedge, cluster-randomised trial undertaken in 121 hospitals across 9 low- to middle-income countries and 1 high-income country. The trial aimed to evaluate a care bundle composed of intensive blood-pressure lowering, rapid correction of hyperglycemia, fever control, and reversal of anticoagulation; in adults presenting within 6 h of ICH onset. We used mixed-effects logistic regression to evaluate sex differences in access to surgical interventions, admission to an intensive care unit or acute stroke unit, assisted feeding, physiotherapy, occupational therapy, withdrawal of care, and use of pharmacological therapies (antiepileptic drugs, mannitol, dexamethasone, and statins). Patterns of care were further evaluated using latent class analysis, with sex differences analyzed using the same regression framework.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>Of 7036 patients with ICH, 2533 (36%) were female. Females were older and had more severe neurological deficits. Overall care provision was similar across sexes. However, females were more likely to receive assisted feeding (odds ratio [OR] 1.15, 95% CI = 1.02–1.31), and were less likely to withdraw from active care (OR 0.41, 95% CI = 0.19–0.87) than males. Surgical interventions were accessed at similar rates among sexes, a finding that persisted in analyses restricted to supratentorial ICH with hematoma volumes ⩾ 30 mL. Three distinct care classes were identified: high-intensity, high-rehabilitation, and low-intensity, with females and males having comparable distributions within the classes.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion:</jats:title> <jats:p>Following acute ICH, females generally receive similar active acute care interventions as males, except for observed differences in access to assisted feeding and decision to withdraw from active care. These findings suggest that equal access to ICH interventions for females and males is feasible and exists in some settings. However, disparities in certain key interventions remain and present actionable opportunities for improvement. Further research is needed to explore not only access but also the timing and frequency of these interventions.</jats:p> </jats:sec> <jats:sec> <jats:title>Data access statement:</jats:title> <jats:p>Individual, de-identified participant data used in these analyses will be shared on request from any qualified investigator after the approval of a protocol and signed data access agreement via both the trial steering committee and the research office of The George Institute for Global Health (Sydney, NSW, Australia).</jats:p> </jats:sec>
1
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Addressing sex and gender differences in stroke risk and management: A scientific statement from the World Stroke Organization
(SAGE Publications, 2025-10-23)
Cheryl Carcel
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Else Charlotte Sandset
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Mariam Ali
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Maria Ignacia Allende Echanez
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Maria Giulia Mosconi
<jats:p>This World Stroke Organization Scientific Statement highlights how sex and gender differences shape stroke risk, treatment, care, and research. Estrogen confers a relative protection before menopause, with risk increasing thereafter. Beyond shared cardiovascular determinants (hypertension, atrial fibrillation, and diabetes), women face sex-specific risks—hypertensive disorders of pregnancy, menopause, and hormone therapy, with clear implications for stroke prevention and management. Despite comparable efficacy of acute and secondary stroke therapies in women and men, women are less likely to receive timely acute treatment and often experience delays in recognition and access. The statement recommends gender-responsive prevention and care pathways; systematic consideration of pregnancy-related and menopausal factors; and public and professional education to improve stroke symptom recognition and purposeful inclusion of women across the research continuum. By integrating evidence from epidemiology, acute care, and secondary prevention, this statement provides clear and timely guidance for reducing inequities and shaping future research and policy to achieve equitable stroke care globally.</jats:p>
1
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STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection
(BMJ, 2025-04)
Carlos Delfino
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Cheryl Carcel
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Xiaolei Lin
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MUÑOZ VENTURELLI, PAULA ANDREA
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Sharon L Naismith
<jats:sec> <jats:title>Introduction</jats:title> <jats:p>Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and analysis</jats:title> <jats:p>The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.</jats:p> </jats:sec> <jats:sec> <jats:title>Ethics and dissemination</jats:title> <jats:p>This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration number</jats:title> <jats:p>The study protocol is registered at Clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04904536">NCT04904536</jats:ext-link>).</jats:p> </jats:sec>
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Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials
(Elsevier BV, 2025-07)
Xia Wang
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Xinwen Ren
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Qiang Li
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Menglu Ouyang
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Chen Chen
Scopus© Citations 1 2
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Stroke care and collaborative academic research in Latin America
(2022)
MUÑOZ VENTURELLI, PAULA ANDREA
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RECULE GONZALEZ, FRANCISCA
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Francisca Urrutia
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MAZZON AGURTO, ENRICO
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NAVIA GONZALEZ, VICTOR HUGO
<jats:p>Objective. A narrative overview of regional academic research collaborations to address the increasing burden and gaps in care for patients at risk of, and who suffer from, stroke in Latin America (LA). Materials and methods. A summary of experiences and knowledge of the local situation is presented. No systematic literature review was performed. Results. The rapidly increasing burden of stroke poses immense challenges in LA, where prevention and management strategies are highly uneven and inadequate. Clinical research is increasing through various academic consortia and networks formed to overcome structural, funding and skill barriers. However, strengthening the ability to generate, analyze and interpret randomized evidence is central to further develop effective therapies and healthcare systems in LA. Conclusions. Regional networks foster the conduct of multicenter studies –particularly randomized controlled trials–, even in resource-poor regions. They also contribute to the external validity of international studies and strengthen systems of care, clinical skills, critical thinking, and international knowledge exchange.</jats:p>
10 1Scopus© Citations 5
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Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2
(2020)
Else Charlotte Sandset
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Xia Wang
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Cheryl Carcel
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Shoichiro Sato
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Candice Delcourt
<jats:sec><jats:title>Introduction</jats:title><jats:p> Reports vary on how sex influences the management and outcome from acute intracerebral haemorrhage. We aimed to quantify sex disparities in clinical characteristics, management, including response to blood pressure lowering treatment, and outcomes in patients with acute intracerebral haemorrhage, through interrogation of two large clinical trial databases. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Post-hoc pooled analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2, where patients with a hypertensive response (systolic, 150–220 mmHg) after spontaneous intracerebral haemorrhage (<6 h) were randomised to intensive (target <140 mmHg <1 h) or guideline-recommended (<180 mmHg) blood pressure lowering treatment. The interaction of sex on early haematoma growth (24 h), death or major disability (modified Rankin scale scores 3–6 at 90 days), and effect of randomised treatment were determined in multivariable logistic regression models adjusted for baseline confounding variables. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In 3233 participants, 1191 (37%) were women who were significantly older, had higher baseline National Institutes of Health Stroke Scale scores and smaller haematoma volumes compared to men. Men had higher three-month mortality (odds ratio 1.48, 95% confidence interval 1.10–2.00); however, there was no difference between women and men in the combined endpoint of death or major disability. There were no significant sex differences on mean haematoma growth or effect of randomised blood pressure lowering treatment. </jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had more comorbidities, larger baseline haematoma volumes and higher mortality after adjustment for age, as compared with women. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had a greater odds of dying after intracerebral haemorrhage than women, which could not be readily explained by differing casemix or patterns of blood pressure management. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> The Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials studies are registered with ClinicalTrials.gov (NCT00226096 and NCT00716079). </jats:p></jats:sec>
Scopus© Citations 15 30
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Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial-2 Results
(2016)
Cheryl Carcel
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Xia Wang
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Shoichiro Sato
;
Christian Stapf
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Else Charlotte Sandset
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Degree and timing of blood pressure (BP) lowering treatment in relation to hematoma growth were investigated in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial-2 (INTERACT2).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>INTERACT2 was an international clinical trial of intensive (target systolic BP [SBP], <140 mm Hg) versus guideline-recommended (SBP, <180 mm Hg) BP lowering in 2839 patients within 6 hours of spontaneous intracerebral hemorrhage and elevated SBP (150–220 mm Hg), in which 964 had repeat cranial computed tomography at 24 hours. ANCOVA models assessed categories of SBP reduction and time to target SBP on 24-hour hematoma growth.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> Greater SBP reduction was associated with reduced hematoma growth (13.3, 5.0, and 3.0 mL for <10, 10–20, and ≥20 mm Hg, respectively; <jats:italic>P</jats:italic> trend<0.001). In the intensive treatment group (n=491), the least mean hematoma growth was in patients who achieved target SBP <1 hour (2.6 mL) versus to those in target at 1 to 6 (4.7 mL) and >6 hours (5.4 mL). The smallest mean absolute hematoma growth (2.0 mL) was in those achieving target SBP 5 to 8 times versus 3 to 4 (3.1 mL) and 0 to 2 times (5.2 mL). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Intensive BP lowering with greater SBP reduction, which is achieved quickly and maintained consistently, seems to provide protection against hematoma growth for 24 hours.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00716079. </jats:p> </jats:sec>
Scopus© Citations 50 1
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Prognostic Significance of Hyponatremia in Acute Intracerebral Hemorrhage: Pooled Analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial Studies
(2016)
Cheryl Carcel
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Shoichiro Sato
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Danni Zheng
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Emma Heeley
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Hisatomi Arima
8Scopus© Citations 41
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Sex differences in treatment and outcome after stroke Pooled analysis including 19,000 participants
(2019)
Cheryl Carcel
;
Xia Wang
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Else Charlotte Sandset
;
Candice Delcourt
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Hisatomi Arima
<jats:sec><jats:title>Objective</jats:title><jats:p>To explore the sex differences in outcomes and management after stroke using a large sample with high-quality international trial data.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Individual participant data were obtained from 5 acute stroke randomized controlled trials. Data were obtained on demographics, medication use, in-hospital treatment, and functional outcome. Study-specific crude and adjusted models were used to estimate sex differences in outcomes and management, and then pooled using random-effects meta-analysis.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>There were 19,652 participants, of whom 7,721 (40%) were women. After multivariable adjustments, women with ischemic stroke had higher survival at 3–6 months (odds ratio [OR] 0.82, 95% confidence interval [CI] 0.70–0.97), higher likelihood of disability (OR 1.20, 95% CI 1.06–1.36), and worse quality of life (weighted mean difference −0.07, 95% CI −0.09 to 0.04). For management, women were more likely to be admitted to an acute stroke unit (OR 1.17, 95% CI 1.01–1.34), but less likely to be intubated (OR 0.58, 95% CI 0.36–0.93), treated for fever (OR 0.82, 95% CI 0.70–0.95), or admitted to an intensive care unit (OR 0.83, 95% CI 0.74–0.93). For preadmission medications, women had higher odds of being prescribed antihypertensive agents (OR 1.22, 95% CI 1.13–1.31) and lower odds of being prescribed antiplatelets (OR 0.86, 95% CI 0.79–0.93), glucose-lowering agents (OR 0.86, 95% CI 0.78–0.94), or lipid-lowering agents (OR 0.85, 95% CI 0.77–0.94).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This analysis suggests that women who had ischemic stroke had better survival but were also more disabled and had poorer quality of life. Variations in hospital and out-of-hospital management may partly explain the disparities.</jats:p></jats:sec>
1Scopus© Citations 115 2

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