ISRCTN47823388已完成未知
Safety and efficacy of intensive versus guideline antiplatelet therapy in high-risk patients with recent ischaemic stroke or transient ischaemic attack: a randomised controlled trial
niversity of Nottingham (UK)0 个研究点目标入组 5,000 人开始时间: 2009年1月23日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 5,000
研究概览
简要总结
2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26079743 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29274727 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30179153 results 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37474599/ (added 21/07/2023) 2023 Results article in https://doi.org/10.1016/j.conctc.2023.101186 Re-Assessment of the TARDIS trial (added 25/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 19/06/2014:
- •Adults at high risk of recurrent ischaemic stroke:
- •1. Age =50 years
- •2. Within 48 hours of ictus (24-48 hours if thrombolysed)
- •3. TIA with limb weakness and/or dysphasia lasting between 10 minutes and <24 hours with no residual symptoms and presenting with any of the following:
- •3.1. ABCD2 score >4
- •3.2. Crescendo TIA
- •3.3. Already on dual antiplatelet therapy with aspirin and dipyridamole
- •3.4. Positive neuroimaging evidence to support the new event, ischaemic stroke on MR diffusion imaging
- •1. Patients who are on monotherapy e.g. aspirin alone, or clopidogrel alone, or dipyridamole alone, are eligible for recruitment. Similarly, patients who are on combined therapy aspirin + dipyridamole, are eligible for recruitment if they fulfil the above criteria.
- •2. Patients with posterior fossa events are eligible if they fulfil the above criteria.
- •3. Neuroimaging is not necessary for transient ischaemic attack. Crescendo TIA is >1 TIA in 1 week and the onset time of last TIA is taken as time of ictus.
- •4. Ischaemic non-cardioembolic stroke presenting with any of the following:
- •4.1. Ongoing limb weakness of more than 1 hour duration; and/or
- •4.2. Ongoing dysphasia of more than 1 hour duration; and/or
- •4.3. Resolved limb weakness of more than 1 hour duration with ongoing facial weakness; and/or
- •4.4. Ongoing isolated hemianopia of more than 1 hour duration with positive neuroimaging evidence to support the new event (e.g. ischaemic stroke in the occipital lobe) and/or
- •4.5. Limb weakness that resolves between 24-48 hours after onset; and/or
- •4.6. Dysphasia that resolves between 24-48 hours after onset; and/or
- •4.7. Positive neuroimaging to support the new ischaemic event with MR diffusion.
- •4.8. Already on combined dual antiplatelet therapy (aspirin + dipyridamole)
- •Neuroimaging is essential for ischaemic stroke to exclude intracranial haemorrhage and a non-stroke diagnosis. If the patient received thrombolysis, a post-thrombolysis/pre-TARDIS scan needs to be done to exclude new thrombolysis-associated bleeding prior to enrolment. Typically this is done routinely as ?standard of care?, but if it is not done, then it must be done prior to enrolment.
- •5. Patients thrombolysed for stroke with full recovery in less than 24 hours from the onset of symptoms are eligible for inclusion providing neuroimaging post thrombolysis excludes intracranial haemorrhage.
- •6. Informed consent from participant. If the participant is unable to give meaningful consent e.g. due to dysphasia, confusion, or reduced conscious level, proxy consent may be obtained from a relative, carer or legal representative.
- •Inclusion criteria from 25/03/2010 to 19/06/2014:
- •Adults at high risk of recurrent ischaemic stroke:
- •1. Acute non-cardioembolic ischaemic stroke (<48 hours of onset). All strokes must have motor weakness or dysphasia at the time of randomisation.
- •2. Acute TIA (<48 hours of onset) with one or more of: crescendo TIA (>1 TIA within 1 week), and/or admitted on dual antiplatelet t
排除标准
- •Current exclusion criteria as of 19/06/2014:
- •1. Age <50
- •2. Isolated sensory symptoms or vertigo/dizziness or facial weakness
- •3. Isolated hemianopia without positive neuroimaging evidence
- •4. Intracranial haemorrhage
- •5. Baseline neuroimaging showing parenchymal haemorrhagic transformation (PH I/II) of infarct, subarachnoid haemorrhage or other non-ischaemic cause for symptoms
- •6. Presumed cardioembolic stroke (e.g. history or current AF, myocardial infarction within 3 months)
- •7. Participants with contraindications to, or intolerance of, aspirin, clopidogrel or dipyridamole.
- •8. Participants with definite need for treatment with aspirin, clopidogrel or dipyridamole individually or in combination (e.g. aspirin and clopidogrel for recent MI/acute coronary syndrome)
- •9. Definite need for full dose oral (e.g. warfarin, dabigatran) or medium to high-dose parenteral (e.g. heparin) anti-coagulation. NB Low-dose heparin for DVT prophylaxis is allowed
- •10. Definite need for glycoprotein IIb-IIIa inhibitors
- •11. Patients who have received thrombolysis within 24 hours
- •12. No enteral access
- •13. Pre-morbid dependency (mRS>2).
- •14. Severe high BP (BP >185/110 mmHg).
- •15. Haemoglobin less than 10 g/dL
- •16. Platelet count more than 600 x 109 /L or less than 100 x 109 /L
- •17. White cell count more than 30 x 109 /L or less than 3.5 x 109 /L
- •18. Major bleeding within 1 year (e.g. peptic ulcer, intracerebral haemorrhage)
- •19. Planned surgery during 3-month follow-up (e.g. carotid endarterectomy)
- •20. Concomitant STEMI or NSTEMI.
- •21. Stroke secondary to a procedure (e.g. carotid or coronary intervention)
- •22. Coma (GCS<8)
- •23. Non-stroke life expectancy <6 months
- •24. Dementia
- •25. Participation in another drug or devices trial concurrently or within 30 days (participants may take part in observational studies or non-drug or devices trials)
- •26. Geographical or other factors that may interfere with follow-up e.g. no fixed address or telephone contact number, not registered with a GP, or overseas visitor.
- •27. Females of childbearing potential, pregnancy or breastfeeding
- •28. Patients who have not had post-thrombolysis neuroimaging.
- •29. Patients on aspirin and clopidogrel prior to the underlying event.
- •Exclusion criteria from 25/03/2010 to 19/06/2014:
- •1. Age <50
- •2. Motor weakness or dysphasia lasting <10 minutes
- •3. Pure sensory, vertigo or dizziness, speech or visual disturbance symptoms without weakness or dysphasia
- •4. Patients with contraindications to, or intolerance of, aspirin, clopidogrel or dipyridamole
- •5. Patients with definite need for treatment with clopidogrel (e.g. recent MI)
- •6. Pre-morbid dependency (mRS>2)
- •7. No enteral access
- •8. Parenchymal haemorrhagic transformation (PH I/II), subarachnoid haemorrhage or other non ischaemic cause for weakness
- •9. TIA not fulfilling inclusion criteria
- •10. Definite need for full dose or
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