scholarly journals Personalised antiplatelet therapy based on pharmacogenomics in acute ischaemic minor stroke and transient ischaemic attack: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028595
Author(s):  
Xiao-Guang Zhang ◽  
Xiao-Qiong Zhu ◽  
Jie Xue ◽  
Zhi-Zhang Li ◽  
Hua-Yu Jiang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Antiplatelet Therapy ◽  
Clinical Features ◽  
Transient Ischaemic Attack ◽  
Genetic Information ◽  
Controlled Trial ◽  
Minor Stroke ◽  
Standard Group ◽  
Ischaemic Attack ◽  
Randomised Controlled

IntroductionAntiplatelet therapy combining aspirin and clopidogrel is considered to be a key intervention for acute ischaemic minor stroke (AIMS) and transient ischaemic attack (TIA). However, the interindividual variability in response to clopidogrel resulting from the polymorphisms in clopidogrel metabolism-related genes has greatly limited its efficacy. To date, there are no reports on individualised antiplatelet therapy for AIMS and TIA based on the genetic testing and clinical features. Therefore, we conduct this randomised controlled trial to validate the hypothesis that the individualised antiplatelet therapy selected on the basis of a combination of genetic information and clinical features would lead to better clinical outcomes compared with the standard care based only on clinical features in patients with AIMS or TIA.Methods and analysisThis trial will recruit 2382 patients with AIMS or TIA who meet eligibility criteria. Patients are randomly assigned in a 1:1 ratio to pharmacogenetic group and standard group. Both groups receive a loading dose of 300 mg aspirin and 300 mg clopidogrel on day 1, followed by 100 mg aspirin per day on days 2–365. The P2Y12 receptor antagonist is selected by the clinician according to the genetic information and clinical features for pharmacogenetic group and clinical features for the standard group on days 2–21. The primary efficacy endpoint is a new stroke event (ischaemic or haemorrhagic) that happens within 1 year. The secondary efficacy endpoint is analysed as the individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death). Baseline characteristics and outcomes after treatment will be evaluated.Ethics and disseminationThis protocol has been approved by the ethics committee of Yangpu Hospital, Tongji University School of Medicine (No. LL-2018-KY-012). We will submit the results of this trial for publication in a peer-reviewed journal.Trial registration numberChiCTR1800019911; Pre-results.

scholarly journals Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM): Protocol for a feasibility randomised controlled trial

2020 ◽  
Vol 2 ◽  
pp. 24
Author(s):  
Eirini Kontou ◽  
Marion Walker ◽  
Shirley Thomas ◽  
Caroline Watkins ◽  
Holly Griffiths ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Transient Ischaemic Attack ◽  
Controlled Trial ◽  
Intervention Group ◽  
Minor Stroke ◽  
Control Group ◽  
Warning Sign ◽  
Feasibility Randomised Controlled Trial ◽  
Ischaemic Attack ◽  
Randomised Controlled

Background: A transient ischaemic attack (TIA) and minor stroke are medical emergencies and often a warning sign of future strokes if remain untreated. Few studies have investigated the long-term psychosocial effects of TIA and minor stroke. Secondary prevention and medical management are often the primary focus with limited access offered for further psychosocial support. Psychoeducational interventions can provide education and advice to people with physical health conditions and, with suitable tailoring, could be appropriate for people after TIA and minor stroke. This study aims to develop a group psychoeducational intervention for people after TIA and minor stroke and to test whether it is acceptable and feasible. Methods: This mixed-methodology study involves two phases: Phase 1) A qualitative study to determine the content of a suitable intervention; Phase 2) A single-centre feasibility randomised controlled trial to evaluate the acceptability of this intervention. The overall study has ethical approval. Stroke survivors have been involved in designing and monitoring the trial. The aim is to recruit 30-40 participants from a Stroke/TIA Service, within 6 months following their diagnosis. Participants will be randomly allocated to either the usual care control group or the intervention group (psychoeducational programme). The programme will consist of six group sessions based on providing education, psychological and social support. The primary outcomes will relate to the feasibility aims of the study. Outcomes will be collected at 3 and 6 months to assess mood, quality of life, knowledge and satisfaction, and resource use. Discussion: There is a need to develop and evaluate effective interventions that enhance the education provided to people after TIA and minor stroke and to promote their psychosocial wellbeing. Findings will indicate the acceptability of the intervention and parameters needed to conduct a definitive trial. Registration: ClinicalTrials.gov ID NCT02550392; registered on 15 September 2015; status: completed.

scholarly journals Appropriateness of general practitioner imaging requests for transient ischaemic attack patients: secondary analysis of a cluster randomised controlled trial

2017 ◽  
Vol 9 (2) ◽  
pp. 131 ◽  
Author(s):  
Annemarei Ranta ◽  
Mark Weatherall ◽  
John Gommans ◽  
Murray Tilyard ◽  
Des Odea ◽  
...  
Keyword(s):  
Decision Support ◽  
Randomised Controlled Trial ◽  
Transient Ischaemic Attack ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Electronic Decision Support ◽  
Investigation Methods ◽  
Ischaemic Attack ◽  
Randomised Controlled ◽  
The Impact

Abstract AIMS Many transient ischaemic attack (TIA) patients receive initial assessments by general practitioners (GPs). In a randomised controlled trial (RCT) we showed that BPAC Inc. TIA/stroke electronic decision support (EDS) for GPs improves patient outcomes and guideline adherence. This secondary analysis assesses the impact of trial associated enhanced GP access to radiological investigation. METHODS Post-hoc analysis of a multi-centre, single blind, parallel group, cluster RCT comparing TIA/stroke EDS guided GP management with usual care to assess whether imaging requests and their appropriateness differed between study groups. RESULTS GPs requested 15/291 (5.2%) carotid ultrasounds and 19/291 (6.5%) computed tomography (CT) head scans. Scans were obtained more frequently in the intervention group (ultrasound cluster adjusted OR (95% CI) 1.41 (0.44 to 4.49), P = 0.56 and CT 13.8 (1.7 to 110.7), P < 0.001). All CTs were clinically appropriate. More ultrasounds were appropriate in the EDS group (cluster adjusted OR (95% CI) of 8.4 (0.39 to 92.3), P = 0.18). Overall investigation costs did not differ between groups (P = 0.83). Some apparent avoidable imaging duplication occurred where patients were subsequently assessed by secondary services. CONCLUSION In the setting of a RCT assessing GP electronic decision support, frequency of GP initiated imaging requests was low and largely appropriate especially in the setting of EDS use. Thus enhanced GP imaging access as part of the EDS tool did not result in inappropriate or excessive GP imaging requests. However, some duplication occurred and practitioners need to ensure that test referrals and results are adequately communicated between sectors.

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