Abstract 189: Intensive Versus Guideline Antiplatelet Therapy For Preventing Recurrence In Patients With Acute Ischaemic Stroke Or TIA: Results In Minor Stroke And TIA From The Triple Antiplatelets For Reducing Dependency In Ischaemic Stroke (TARDIS) Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Philip M Bath ◽  
Lisa J Woodhouse ◽  
Katie Flaherty ◽  
Diane Havard ◽  
Timothy J England ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Controlled Trial ◽  
Antiplatelet Agent ◽  
Data Monitoring Committee ◽  
National Institutes Of Health ◽  
Minor Stroke ◽  
Proxy Consent ◽  
Open Label ◽  
Ischaemic Attack

Background: The risk of recurrence following an ischaemic stroke (IS) or transient ischaemic attack (TIA) is high, especially immediately after the event. Since one antiplatelet agent is more effective than none, and two are are superior to one, even more intensive treatment might be more effective in preventing recurrence. Methods: TARDIS was an international prospective randomised open-label blinded-endpoint controlled trial. Patients with acute (<48 hours) non-cardioembolic IS or TIA were randomised to intensive antiplatelet therapy (combined aspirin, clopidogrel and dipyridamole) or guideline antiplatelets (clopidogrel alone, or combined aspirin and dipyridamole) given for one month. The primary outcome was stroke and TIA recurrence, and their severity (based on modified Rankin Scale), at 3 months. Patients or relatives gave written informed (proxy) consent and all sites had research ethics approval. The trial was funded by the British Heart Foundation and NIHR Health Technology Assessment programme. Results: The Independent Data Monitoring Committee recommended stopping the trial in March 2016 since a definitive result had been reached. Of 3,096 patients, 2213 (71%) were enrolled with minor stroke (NIHSS <=3) or TIA. At baseline: mean age 69 (SD 10); male 62%; prior stroke 10%; diabetes 18%; index event IS 57%, TIA 43%; severity in IS (National Institutes of Health Stroke Scale) 1.8 (1.0); ABCD2 in TIA 5.1 (0.9); onset to randomisation <12 hours 11%, <24 hours 35%. Summary: The results will be available for presentation in quarter 4 2016. TARDIS is large enough to influence clinical practice.

scholarly journals Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a parallel, randomised, open-label, multicentre, prospective study

2018 ◽  
Vol 3 (4) ◽  
pp. 263-267 ◽  
Author(s):  
Xiaowen Hou ◽  
Xiaoqiu Li ◽  
Xinhong Wang ◽  
Huisheng Chen
Keyword(s):  
Adverse Events ◽  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Rational Design ◽  
Dual Antiplatelet Therapy ◽  
Prospective Trial ◽  
Minor Stroke ◽  
Efficacy And Safety ◽  
Open Label ◽  
Nihss Score

BackgroundA recent study shows that dual antiplatelet therapy with clopidogrel plus aspirin is superior to aspirin monotherapy for minor stroke, which is defined as a National Institutes of Health Stroke Scale (NIHSS)score of ≤3. However, acute mild-moderate ischaemic stroke (4≤NIHSS≤10) still needs aggressive antiplatelet intervention to prevent deterioration and recurrence of stroke. The efficacy and safety of dual antiplatelet therapy versus aspirin monotherapy in the population are not clear. A multicentre clinical trial is designed to evaluate the efficacy and safety of clopidogrel plus aspirin therapy versus aspirin monotherapy within 48 hours of symptom onset of mild-moderate ischaemic stroke.Methods/DesignThe study is a randomised, open-label, multicentre, prospective trial with a target enrolment of 2700 patients from 60 centres in Northeast China. A treatment allocation identification number to each enrolled patient will be provided by a random number generator. The follow-up time for the clopidogrel plus aspirin and aspirin monotherapy groups is 90 days. The primary efficacy endpoint is a stroke progression event, which is defined as ≥4 point increase in the NIHSS score in 48 hours. The second efficacy endpoints include new ischaemic stroke within 90 days, change in the NIHSS score within 14 days, modified Rankin Scale score on day 90 and other vascular or death events within 90 days. The safety endpoints include mucocutaneous haemorrhage, organ haemorrhage and intracranial haemorrhage, adverse events and severe adverse events. χ2 test, t-test (or Mann-Whitney test), survival analysis and Cox proportional hazards models will be conducted. The findings of the study may provide an important evidence for clinical practice for these patients.DiscussionThe trial will be conducted under a rational design and will provide valuable evidence on the appropriate treatment for this population.Ethics and disseminationThe study was reviewed and approved by the Ethics Committee of the General Hospital of Shen-Yang Military Region (no K(2016) 6).Trial registration numberNCT02869009; Pre-results.

scholarly journals Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline

BMJ ◽  
2018 ◽  
pp. k5130 ◽  
Author(s):  
Kameshwar Prasad ◽  
Reed Siemieniuk ◽  
Qiukui Hao ◽  
Gordon Guyatt ◽  
Martin O’Donnell ◽  
...  
Keyword(s):  
High Risk ◽  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Transient Ischaemic Attack ◽  
Dual Antiplatelet Therapy ◽  
Recurrent Stroke ◽  
Minor Stroke ◽  
Strong Recommendation ◽  
Ischaemic Attack

What is the role of dual antiplatelet therapy after high risk transient ischaemic attack or minor stroke? Specifically, does dual antiplatelet therapy with a combination of aspirin and clopidogrel lead to a greater reduction in recurrent stroke and death over the use of aspirin alone when given in the first 24 hours after a high risk transient ischaemic attack or minor ischaemic stroke? An expert panel produced a strong recommendation for initiating dual antiplatelet therapy within 24 hours of the onset of symptoms, and for continuing it for 10-21 days. Current practice is typically to use a single drug

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 Comparison of outcome of patients with acute minor ischaemic stroke treated with intravenous t-PA, DAPT or aspirin

2020 ◽  
pp. svn-2019-000319
Author(s):  
Peng Wang ◽  
Mengyuan Zhou ◽  
Yuesong Pan ◽  
Xia Meng ◽  
Xingquan Zhao ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
National Institutes Of Health ◽  
Minor Stroke ◽  
Post Hoc Analysis ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Ischemic Attack ◽  
Post Hoc

BackgroundWhether to treat minor stroke with intravenous tissue plasminogen activator (t-PA) treatment or antiplatelet therapy is a dilemma. Our study aimed to explore whether intravenous t-PA treatment, dual antiplatelet therapy (DAPT) and aspirin have different efficacies on outcomes in patients with minor stroke.MethodsA post hoc analysis of patients with acute minor stroke treated with intravenous t-PA within 4.5 hours from a nationwide multicentric electronic medical record and patients with acute minor stroke treated with DAPT and aspirin from the Clopidogrel with Aspirin in Acute Minor Stroke or Transient Ischemic Attack Database. Minor stroke was defined by a score of 0–3 on the National Institutes of Health Stroke Scale at randomisation. Favourable functional outcome (defined as modified Rankin Scale (mRS) score of 0–1 or 0–2 at 3 months).ResultsCompared with those treated with intravenous t-PA, no significant association with 3-month favourable functional outcome (defined as mRS score of 0–1) was found neither in patients treated with aspirin (87.8% vs 89.4%; OR, 0.83; 95% CI, 0.46 to 1.50; p=0.53) nor those treated with DAPT (87.4% vs 89.4%; OR, 0.84; 95% CI, 0.46 to 1.52; p=0.56). Similar results were observed for the favourable functional outcome defined as mRS score of 0–2 at 3 months.ConclusionsIn our study, no significant advantage of intravenous t-PA over DAPT or aspirin was found. Due to insufficient sample size, our study is probably unable to draw such a conclusion that that intravenous t-PA was superior or non-superior to DAPT.

scholarly journals Clopidogrel plus aspirin versus aspirin alone for acute minor ischaemic stroke or high risk transient ischaemic attack: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k5108 ◽  
Author(s):  
Qiukui Hao ◽  
Malavika Tampi ◽  
Martin O’Donnell ◽  
Farid Foroutan ◽  
Reed AC Siemieniuk ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Absolute Risk ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Ischaemic Attack ◽  
Quality Evidence

AbstractObjectiveTo assess the effectiveness and safety of dual agent antiplatelet therapy combining clopidogrel and aspirin to prevent recurrent thrombotic and bleeding events compared with aspirin alone in patients with acute minor ischaemic stroke or transient ischaemic attack (TIA).DesignSystematic review and meta-analysis of randomised, placebo controlled trials.Data sourcesMedline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Library, ClinicalTrials.gov, WHO website, PsycINFO, and grey literature up to 4 July 2018.Eligibility criteria for selecting studies and methodsTwo reviewers independently screened potentially eligible studies according to predefined selection criteria and assessed the risk of bias using a modified version of the Cochrane risk of bias tool. A third team member reviewed all final decisions, and the team resolved disagreements through discussion. When reports omitted data that were considered important, clarification and additional information was sought from the authors. The analysis was conducted in RevMan 5.3 and MAGICapp based on GRADE methodology.ResultsThree eligible trials involving 10 447 participants were identified. Compared with aspirin alone, dual antiplatelet therapy with clopidogrel and aspirin that was started within 24 hours of symptom onset reduced the risk of non-fatal recurrent stroke (relative risk 0.70, 95% confidence interval 0.61 to 0.80, I2=0%, absolute risk reduction 1.9%, high quality evidence), without apparent impact on all cause mortality (1.27, 0.73 to 2.23, I2=0%, moderate quality evidence) but with a likely increase in moderate or severe extracranial bleeding (1.71, 0.92 to 3.20, I2=32%, absolute risk increase 0.2%, moderate quality evidence). Most stroke events, and the separation in incidence curves between dual and single therapy arms, occurred within 10 days of randomisation; any benefit after 21 days is extremely unlikely.ConclusionsDual antiplatelet therapy with clopidogrel and aspirin given within 24 hours after high risk TIA or minor ischaemic stroke reduces subsequent stroke by about 20 in 1000 population, with a possible increase in moderate to severe bleeding of 2 per 1000 population. Discontinuation of dual antiplatelet therapy within 21 days, and possibly as early as 10 days, of initiation is likely to maximise benefit and minimise harms.

Abstract 207: Vorapaxar in Patients with Prior Ischemic Stroke: Primary Results from the Stroke Cohort of the Multinational TRA 2°P-TIMI 50 Trial

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
David A Morrow ◽  
Mark Alberts ◽  
Jay P Mohr ◽  
Sebastian Ameriso ◽  
Marc Bonaca ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Antiplatelet Therapy ◽  
Controlled Trial ◽  
Antiplatelet Agent ◽  
Antiplatelet Agents ◽  
Primary Efficacy ◽  
Background Therapy ◽  
History Of ◽  
Double Blinded ◽  
Prior Stroke

Vorapaxar is an antiplatelet agent that potently inhibits thrombin-mediated activation of the platelet protease-activated receptor (PAR)-1. Phase 2 trials of vorapaxar suggested efficacy with acceptable safety in patients with ischemic stroke. Methods: TRA 2°P–TIMI 50 was a multinational, randomized, double-blinded, placebo-controlled trial of 26449 patients with a history of atherothrombosis randomized to vorapaxar (2.5 mg daily) or matching placebo added to standard therapy, including antiplatelet agents. Patients who qualified with stroke (N=4883) had a history of ischemic stroke in the prior 2 wks to 12 mo. The first efficacy endpoint was the composite of cardiovascular (CV) death, MI, or stroke. After 2 years, the Data and Safety Monitoring Board recommended discontinuation of study treatment in patients with prior stroke. Results: The qualifying stroke was classified as large vessel in 35%, small vessel in 47%, and other in 18%. Background therapy included aspirin in 81%, clopidogrel in 22%, and dipyridamole in 19%. In the stroke cohort, the 3-year rate of CV death, MI, or stroke was not reduced with vorapaxar vs. placebo (13.0% vs. 11.7%, HR 1.03; 95% CI 0.85-1.25), including recurrent ischemic stroke (HR 0.99; 95% CI 0.78-1.25). There were no statistically significant differences in the effect of vorapaxar based on the type or timing of the qualifying stroke, and a borderline interaction based on co-administration of clopidogrel (Figure) The rate of intracranial hemorrhage (ICH) at 3 years was 2.5% with vorapaxar vs. 1.0% with placebo (HR 2.52; 95% CI 1.46-4.36). Conclusions: In patients with prior stroke receiving standard antiplatelet therapy, adding vorapaxar increased the risk of ICH without a reduction in the primary efficacy endpoint or ischemic stroke. These findings add to the accumulating evidence establishing important risks with combination antiplatelet therapy in patients with prior stroke.

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.

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