Lead Investigator: Andy Lim, Monash University
Title of Proposal Research: Meta-analysis of early stroke recurrence rate in minor stroke
Vivli Data Request: 6866
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Having a ‘mini-stroke’ (TIA = transient ischaemic attack) or ‘minor stroke’ is dangerous to health, as it can signal a recurrent and much larger stroke that can cause disability or death. Most of the previous research efforts have been to measure and reduce this recurrence rate in the TIA group, but ‘minor stroke’ has not had the same attention. Large international trials have been released that shows that this minor stroke group can be helped in a similar way. The next step then is to measure how high the recurrence rate is in this new cohort of patients. That is why we are performing a study called a ‘meta-analysis’, that summarizes all the known recurrence rates that have been published into one single figure. This will help hospitals and health services benchmark their minor stroke interventions.
Previous meta-analytic efforts have focused on stroke recurrence in TIA. However recent clinical trials have demonstrated favourable outcome of early secondary prevention in an extended subgroup that includes minor stroke. Reliable risk estimation of this contemporary cohort is required for service planning given these advances. This study therefore aims to report the early stroke recurrence rate for such a cohort.
Statistical Analysis Plan:
Strategy for data synthesis
Meta-analysis will be performed using the random effects model. Effect sizes will be calculated using the Freeman-Tukey double arcsine transformed proportion, to adjust for the presumed Poisson distribution of the infrequent primary outcome. The restricted maximum-likelihood estimator (REML) method will be used to estimate the amount of heterogeneity. The first analysis will include all minor stroke subsets, pooled together by meta-anaylsis. The second analysis will include combined cohorts of transient ischaemic attack and minor stroke, pooled together by meta-analysis.
Analysis of subgroups or subsets
Meta-regression will be performed if the inconsistency index I² demonstrates high heterogeneity (>75%).
Requested Studies:
Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack (SOCRATES trial)
Sponsor: AstraZeneca
Study ID: NCT01994720
Sponsor ID: NCT01994720
Public Disclosures:
A. Lim, H. Ma, C. Johnson, S. Singhal, S. Muthusamy, Y. Wang, Y. Pan, S. Coutts, A. Ois, M.K Kapral, M. Knoflach, L.J Woodhouse, P.M Bath, T Phan. Ninety-day stroke recurrence rate in minor stroke: a meta-analysis of randomized trials and observational studies. European Stroke Journal. 2022;7(1_suppl):3-545. European Stroke Organisation Conference (ESOC) 2022 Abstract Book, O084 / 129 page 48. doi: 10.1177/23969873221087559.