Ongoing Trials in Europe - ESOTA — ESO Trials Alliance

Ongoing ESOTA Trials

The aim of the Trials Network Committee is to facilitate academic clinical stroke research in Europe.

Within the networks various trials are actively recruiting. We would like to refer to the ‘Member Networks’ page to find more information about clinical studies within each network. Below you can find a link to clinicaltrials.gov which contains an overview of clinical stroke trials in all European countries.

Infortmation concerning funding and insurance can be found here.

Investigators will find the following resources:

Database of ongoing stroke research: A repository of > 100 ongoing clinical stroke studies running in two or more European countries, including information about the coordinating investigators behind these trials. [click here]

An overview of relevant courses and other resources organised and provided by each network can be found on the webpages of the national networks. [click here]

Existing trials collaborating with ESOTA networks

COIchine for prevention of Vascular Inflammation in Non-CardioEmbolic stroke (CONVINCE)

PI: Prof Peter Kelly, U College Dublin – Ireland
Colchicine plus usal care versus usal care alone after ischaemic stroke

Status (August 2023):
Recruitment is closed; full sample size: 3154
UK: 1219
Ireland: 478
Germany: 428
Belgium: 365
Spain: 277
Denmark: 74
Poland: 68
Canada: 36
Switzerland: 22
Czech Republic: 21
Netherlands: 18
Lithuania: 14
Estonia: 12

Patients in follow up until Dec 23/Jan 24

Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillation (ELAN)

PI: Prof Urs Fischer, Inselspital (University Hospital) Bern – Switzerland
Early versus guideline-based introduction of direct oral anticoagulants after ischaemic stroke with atrial fibrillation

Status (August 2023):
Total number of randomised patients: 2013
Total number of randomised patients (ESOTA member countries): 1382
Switzerland: 505
United Kingdom: 482
Belgium: 183
Germany: 195
Ireland: 17

Recruitment ended in September 2022 and the last follow-up was performed in December 2023. The final results were published in The New England Journal of Medicine on May 24^th 2023 and presented at the 9^th European Stroke Organisation Conference in Munich, Germany.

Trials in planning phase collaborating with ESOTA networks

TICH-3

PI: Prof Nikola Sprigg, U Nottingham – UK
Tranexamic acid vs placebo for acute non-traumatic ICH <4.5 hours onset

Overall 392 participants
UK 306 participants have been recruited.
56 UK sites are opened and 52 of these have recruited.

For TICH-3 International, 82 participants have been recruited and there are 19 sites opened: Malaysia: 13, Georgia:3, Denmark: 1, Finland:1, Italy:1
Out of the 19 sites, 14 have recruited. Recruitment open in Italy, Denmark, Finland.

Sites to pen in Ireland, Spain, France, Swizerland soon.

Additional countries sites welcome only if able to secure funding locally.

New sites/investigators contact tich-3@nottingham.ac.uk

ASPIRING (Antiplatelet Secondary Prevention International Randomised trial after Intracerebral haemorrhage)

PI: Prof Rustam al-Shahi Salman, University of Edinburg – UK

The Antiplatelet Secondary Prevention International Randomised trial after INtracerebral haemorrhaGe (ASPIRING) is funded to start in 2024 in the UK, Canada, The Netherlands, and Australia with funding via the GCRFF Multinational Clinical Trials initiative from the British Heart Foundation, Canadian Institutes of Health Research, Dutch Heart Foundation, and National Health and Medical Research Council Medical Research Future Fund respectively.

(Status August 2023)

European blood pressure intensive control after stroke – pilot trial (EPICS-Pilot)

PI: Prof Peter Kelly, University College Dublin – Ireland
ethics applications are underway; aim for first patient is Oct/Nov 2023 (Status: August 2023)