NIHR Multicentre Stroke Studies

 

   

The National Institute for Health Research provides an infrastructure to foster high quality research in the UK. Click the links for Stroke Research and the Clinical Research Network West Midlands for specific detail. Please contact Christine Roffe, the Specialty Lead for Stroke, or Sissi Ispoglou, the deputy lead, for further information. Active studies and stats can be found on the Daily Recruitment Checker. Please find below a list of past and current studies.

Hyperacute Stroke Studies (the first 9 hours)

Biogen Action-2 STRO-30468 RCT ph2 iv Nataluzimab in ischaemic stroke (<9h)
ECASS-4 Extend complex RCT lysis after 4.5 h of  onset, decision making via MRI
EuroHyp-1 complex RCT induced hypothermia for acute stroke
ENCHANTED RCT tight vs standard control of BP after lysis within 4.5 h of onset
PASTA RCT paramedic acute stroke treatment assessment (North East only)
Practise complex RCT decision making for late lysis: perfusion imaging or not?
Pfizer STRO-fs complex ICH ph 1b rct ph2 prothombin acivator<2.5h  -03/17
RIGHT-2 GTN patch vs pacebo for suspected stroke, given in the ambulance
RECAST-2 remote ischemic preconditioning  (Nottingham and Darby only)
SCIL-1 RA  infarct/complex RCT (Manchester only)
Stabilise  complex RCTcomparison of two thrombectomy devices <4.5 h
SmartChip Observational study <4.5 h of onset (Coventry, Salford and Stoke only)
TASTE complex RCT decision making for tenecteplase via perfusion CT
TICH-2 tranexamic acid for intracerebral haemorrhage
Wake Up stroke complex RCT lysis for wake up stroke, decision making via MRI

 
Acute Stroke/ SAH/ TIA/ dissection Studies
Gypsie Glycoprotein 6 in stroke (Canmbridge only) till Sept 2017
MISTIE-3 complex surgery for ICH <48 h alteplase into ventricular  drain
POINT Asprin and clopidogrel vs aspirin within 12 h of onset (on hold June 2016)
RESTORE Servier STRO-4889 RCT GABA antag N7-20 MRI w cort. inf. d2 enrol d3-6
VWF-ADAMTS 13 Observational, Van Willebrand factror (UCL only)


Studies requiring vascular surgery and/or interventional radiology input
ACST-2 Carotid artery surgery or stenting for asymptomatic carotid artery stenosis (select patients where the clinician is uncertain which intervention is better)
ECST-2 Carotid endarterectomy or stenting vs BMT in asymptomatic mild to moderate carotid stenosis (select patients where the clinician is uncertain whether intervention is needed)
Pipleline Flex SFX-01 after SAH Single centre Wessex observational SAH


Rehabilitation and Life after Stroke
Phader STRO 4441 Phagenesis pharyngeal stimulation for dysphagia
ATTEST-Additional trunk training in early stroke (3-7d post stroke Guy's&St T only)
LOTS-2 Care Evaluation of a service initiative giving longer-term support (>6 m)
FOCUS Fluoxetine within 5-15 d of stoke onset (investigator portal)
COGWATCH Rehabilitation for stroke patients who have cognitive difficulties
PLORAS  Observational study: predicting language recovery after stroke
LA-SER PGRX commercial observ. study stroke of undet. origin (close Jan 17)
RESTORE  ph2 RCT GABA rec antagonist S 44819 3-6 days after AIS

 Upcoming studies
*ASSENT Daiichi STRO-4708, complex ph1-2, <8h, needs CTA, (in set up)
*SITS Open complex RCT of thrombectomy vs standard care (CI Mc Walter)
*MAPS-2 RCT of metoclopramide and/or selective oral decontamination for stroke RCT < 9h (EOI Sept 2016, start 03/17)
*MEDIS Pulse Therap. STRO4938 complex hyperacute microspheres RCT (K. Muir) (start Q1 2017)
*TWIST tenecteplase in wake-up stroke (led by Norway, UK CI T. Robinson)
*CHARM Medpace complex RCT glyburide MRI AIS < 9 h NIHSS>=10  Start Q3 2017
*TEMPO-2 complex RCT Tenecteplase AIS NIHSS<=5 <9h w IC occl. or perfusion deficit (CI K. Muir, Mar 2016)
*ATTEST-2 alteplace vs tenecteplase within 4.5 h of onset (CI K Muir)
*PRISMS Genentech RCT Asp vs alteplase nihss<=5 (CI P Khatri) EOI Nov 2016
DNA Lacunar-2 observational needs MRI (CI H Markus) (start late 2016)
PRECIOUS 2x2x2 RCT Metoclop/ceftriax/paracetx4d in AIS<12h N>5 (Worp/ Bath)
CAARBS Which agent for BP in AIS/TIA (CI T.Robinson/ Leics/Oxf/Norw only 03/17)
CONVINCE RCT of oral colchizine in AIS start 03/17 (72h-28 d) CI C. Price
Athersys stem cell trial in stroke patients undergoing rehabilitation EOI 06/2016
PROPS Comb. fixed dose pill (atorv/asp/ramip) to prev. stroke >55yo prim care led
LACI-2 2x2 RCT of cilostazol and/or ISMO x 1y in MRI defined LACI to prevent stroke 
XILO-FIST RCT allopurinol vs control <30 d mri at baseline and 2 years CI J Dawson
SoSTART AF and ICH to anticogulae or not RCT Rustam A-Shahi-Salman
005578 Pharm Olam ph 2a RCT angiogenesis in AIS 24-72h N8-20 (EOI Feb 2017)

Possible future studies (pre funding EOIs)
*DASH Desmopressin for ICH with  Antiplatelet CI N Sprigg EOI Nov 2016
*PISTE AI decision making for thrombecomy  (P. White awaitng funding decision Mid 2017)
R4VAD Therapy trial J Wardlaw Observational cogn. decline EOI Sept 2016
RAPPSTAR RCT repetetive funct practice in the community H Rodgers EOI Aug 2016
MAGiC 2x2 RCT mannitol/gliblenclamide <72h post AIS (NIHSS>15) N.Sprigg Q1 2018
FISHES D. Day Cambridge iv fluids within 4 h of AIS RfPB Jan 2018
ELAN early vs delayed anticoag w. DOAC in AIS<48h and AF EOI 01/17 J Dawson
OPTIMAS early vs delayed anticoag.w DOAC in AIS<4d & AF EOI 02/17 7D. Werring
TIMING Swedish study of early vs delayed anticoag for AIS and AF
Observational registry of a DOAC (TBC Jan 2017)
Industry Study Rehabilitation device  Mindmaid (TBC Jan 2017)


Studies not started /not running in the UK
*STRO-347  ph 1b mRCT <4.5 h if thrombolysis not indicated (Parexel, pre Oct 2014)
Socrates-2 STRO 32062 RCT of ticagrelor&AIS <24h (Not open in UK)
Pharma  SFX01 after SAH  (on hold till Feb 2014)

Studies closed to recruitment

FAST INDICATE Functional Strength Training to reduce arm weakness
EXTRAS RCT of an extended supported discharge service for stroke patients

RAPID TIA (Rapid Primary Care Initiation of Drug treatment for TIA pilot RCT)HEADPost cluster RCT of head position after stroke
GLORIA AF Observational study of patients newly anticoagulated for AF Boehringer
PRESERVE BP control in patients with small vessel disease, needs MRI at baseline
GORE REDUCE closure vs antiplatelets alone for PFO (UHB only in WMIDS)
PISCES-2 RENEURON 002: RCT of stem cell treatment for stroke recovery
OCScare/BCoS Care Observational study of cognitive outcome after stroke
TARDIS P-Selectin sub-Study EOI June 2015 (TARDIS Centres only)
TARDIS triple antiplatelets <72 h from onset of stroke or TIA
CROMIS 2 observational study of microbleeds in anticoagulated patients, requires MR
SMARTcap observational study of a blood test for the diagnosis of stroke
PISTE thrombectomy in patients with MCA /carotid T occlusion -study closed Sept 2015
OSIS RENEURON RN-CS-0001: observational study of stroke outcome Closed Aug 2015
CLOTBUST Ultrasond enhanced thrombolysis within 4.h of stroke onset.  Stopped 2015
ARTSS 2b Direct thrombin inhibtor (agatroban) infusionx48h& tpa vs tpa within 4.5h Stopped 2015
MULTISTEM Athersys Phase-II RCT adult human stem cells iv within 36 h of onset complete 2014
Dias-4 thrombolysis <9 hrs form onset (looking for new centres)
SOS Penumbra observational <9 h of onset NIHSS>9, large artery occlusion on CTA 
VIST stenting for symptomatic (within 6 mo) atheroslerotic vertebral artery stenosis
VCT-returns (Visual Cue training for walking and turning after stroke pilot RCT)
SO2S oxygen supplementation <24 hrs form onset
BMS phase 4 apixaban with and without extra support  RCT  in patients with AF
REFLEX Botox treatment in stroke rehabilitation (commercial)
PODCAST Prevention Of Decline in Cognition After Stroke Trial: BP control in primary care
DARS Dopamine Augmented Rehabilitation in Stroke. Enrol within 14 days of stroke onset.
ATRAS study Assistive Technologies in Upper Limb Rehabilitation
TBS effect of repetitive Transcranial magnetic stimulation on arm function >1y from stroke
EUBOSS (Early Use of Botulinum Toxin in post Stroke Spasticity) (Birmingham only)
BCoSlite (Improving diagnosis and treatment of cognitive problems after stroke)
GOSH Case-control study of genetic polymorphisms in aneurysmal SAH
FACE TIA Cognitive problems after TIA (observational study) looking for centres in  WMIDS (slides)
DNA Lacunar Lacunar infarct on MRI and clinically and <70
BUCS observational study, application of the Birmingham University Cognitive Screen
LoTS CARE patient and carer-centred system for longer-term stroke care patients result
LUNS observational study of Longer-term Unmet Needs after Stroke (closed January 2011)
OTCH OT in care homes
Modified Rankin Scale < 48 h form onset observational study of pre-stroke Rankin
Clear 2 thrombolysis for intraventricular haemorrhage <24 h from onset
TALECRIS Intra-thrombus plasmin in MCA stroke <8.5 h from onset. Open label, dose escalation.
MASH-2 (<4 days) Magnesium infusion in subarachnoid haemorrhage
STASH  (<4 days) Simvastatin after acute SAH confirmed by CT angio or equivalent
SRN024 - (Mitsubishi) a phase IIa study of MCI186 in subjects within 72 h of onset
SRN018 (ARC 1779) ARCHEMIX ARC1779 Cerebral Microembolism in Patients Undergoing CEA
PRET patients with at least one aneurysm prone to recurrence amenable to coiling (closes 06/11)
PAST-BP  trial of different blood pressure targets for people with a history of stroke or TIA
LILACS small vessel disease <85 (n=40)

Studies not opened in the UK
Impact24B complex Sphenopalatine ganglion stimulation to increase CBF witihin 8-24 h (not in UK)

 
Published Results of Studies the WMIDS Stroke LRN has contributed to
PISTE thrombectomy in patients with MCA/carotid-T occlusion -study RESULT

STEPS pharyngeal stimulation  in the tx of dysphagia <6 weeks form stroke RESULT

STROKE-INF prophylactic antibiotics for dysphagic stroke(<48 h) RESULTS
CADISS (<7 days of symptom onset) antiplatelet agents or warfarin for extracranial carotid or vertebral artery dissection
ENOS GTN patch and starting/stopping existing antihypertensives <48 h form onset
INTERACT 2  intensive blood pressure lowering after ICH  Results presented at ESC May 2013. Strong trend for better outcome with tight blood pressure control. NEJM paper
CLOTS-3 mechanical compression for DVT prevention < 72 h of stroke Results May 2013. Intermittent pneumatic compression stockings save lives after stroke!
STICH-II (<48 h) of Lobar Intracerebral Haemorrhage Results ESC 2013. Strong trend towards better outcome with early surgery. 
ARUBA unruptured brain arteriovenous malformations randomized to active intervention to eliminate the AVM (including surgery, catheter embolization or radiation therapy) or no intervention, stopped 15.04.2013 because of significantly higher mortality in the intervention group. Presented at ESC London, May 2013, publication awaited.
IST-3 thrombolysis <6 h form onset (results) June 2012. Thrombolysis is effective in over 80s and in big strokes. Time is brain treatment most effective within 3 h of onset.
ROCKET comparing an new anticoagulant (rivaroxaban) with warfarin pre-publication press release by Bayer, The Heart Org summary of AHA presentation of Rocket results Dec 2010
ACT NOW: enhanced speech and language therapy (HTA report  results )
VITATOPS: Results as reported at the European Stroke Conference 2010, abstract
CLOTS-trial 1: TED stockings versus no stockings abstract free full text
CLOTS-trial 2: long stockings versus short stockings abstract medscape review
COSSACS: continue or stop blood pressure tablets during the first 2 weeks after stroke abstract
PERFORM: aspirin versus new antiplatelet (terutroban) agent for stroke prevention slide abstract
PROFESS: aspirin and dipyridamole vs clopidogrel abstract and link to free manuscript
PROFESS: telmisartan vs placebo abstract and link to free manuscript