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

AMASCIS (Autologous Mesenchymal Stem Cells in Ischaemic Stroke)

Principal Investigator: Prof Exuperio Díez Tejedor

AMASCIS investigates the safety and feasibility of using autologous mesenchymal stem cells in patients with ischaemic stroke. This early-phase study explores the potential for regenerative therapies in stroke recovery.

Status: Ongoing
ClinicalTrials.gov ID: NCT01678534

BIRCH (A study to evaluate the safety, tolerability and the effects of Ixodes ricinus-Contact Phase Inhibitor (Ir-CPI) in adult patients with spontaneous intracerebral haemorrhage))

Principal Investigator: Belgium-based study

A study to evaluate the safety, tolerability and the effects of Ixodes ricinus-Contact Phase Inhibitor (Ir-CPI) in adult patients with spontaneous intracerebral haemorrhage.

Status: Ongoing
https://euclinicaltrials.eu/ctis-public/view/2022-500491-53-00ClinicalTrials.gov ID: NCT05970224

BRIGHT (Phase IIb Study of LT3001 in Acute Ischemic Stroke)

Principal Investigator: Dr. Thomas Devlin

The BRIGHT study is a multinational, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating the safety and efficacy of multiple doses of LT3001 (odatroltide) in patients with acute ischemic stroke (AIS) who are not eligible for thrombolysis or mechanical thrombectomy. LT3001 is a novel small synthetic peptide designed to restore cerebral blood flow and reduce reperfusion injury.

The trial plans to enroll approximately 200 participants across multiple countries, including the United States, Taiwan, and Greece.

Status: Recruiting (as of March 2025)
ClinicalTrials.gov ID: NCT05403866

CASES (Carotid Artery Stenting during Endovascular Treatment of Acute Ischemic Stroke versus Deferred Stenting)

Principal Investigator: Prof Dr M Uyttenboogaart / Belgium-based study

CASES is a multicentre trial investigating the benefits and risks of immediate versus deferred carotid artery stenting in patients undergoing endovascular treatment for acute ischaemic stroke. The trial aims to optimise stroke care by informing procedural timing for carotid intervention.

Status: Ongoing
More information

CHOICE-2 (Intra-arterial Administration of Alteplase After Thrombectomy)

Principal Investigator: Dr Angel Chamorro

CHOICE-2 builds upon earlier studies by evaluating intra-arterial alteplase administration immediately following thrombectomy. The goal is to enhance recanalisation quality and improve clinical outcomes in acute ischaemic stroke.

Status: Ongoing
ClinicalTrials.gov ID: NCT03876119

DIST (Dutch ICH Surgery Trial)

PI: Prof. Dr. Karin Klijn, Radboud University Medical Center – The Netherlands

DO-IT (Thrombolysis in patients treated with NOACS)

PI: Dr Thomas Meinel, University of Bern – Switzerland

https://clinicaltrials.gov/study/NCT06571149

ELAPSE (Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy)

Principal Investigator: Prof. Lorenz Räber

The ELAPSE study investigates early closure of the left atrial appendage as a preventive strategy in atrial fibrillation patients who suffer an ischaemic stroke despite anticoagulation. The trial focuses on reducing recurrence rates and improving long-term outcomes.

Status: Ongoing
ClinicalTrials.gov ID: NCT05976685

ENRICH-AF (EdoxabaN for IntraCranial Hemorrhage Survivors with Atrial Fibrillation)

Principal Investigator: Dr. Ashkan Shoamanesh

ENRICH-AF is an international, Phase 4, randomized, open-label, blinded-endpoint (PROBE) clinical trial evaluating the efficacy and safety of edoxaban in patients with atrial fibrillation (AF) who have survived an intracranial hemorrhage (ICH). The study aims to determine whether edoxaban reduces the risk of stroke or systemic embolism compared to standard medical therapy (no antithrombotic therapy or antiplatelet monotherapy) in this high-risk population.

The trial plans to enroll approximately 1,380 participants across 238 sites in 20 countries, including 14 European countries.

Status: Active, not recruiting (as of January 2025)
ClinicalTrials.gov ID: NCT03950076

FibER (Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischaemic Stroke Patients After Thrombolysis)

Principal Investigator: Italy-based study

FibER is a pilot randomised controlled trial evaluating whether fibrinogen replacement can prevent intracranial haemorrhage in ischaemic stroke patients following thrombolysis. The trial will help define future protocols for haemorrhage prevention.

Status: Ongoing
ClinicalTrials.gov ID: NCT0530067
EudraCT Number: 2020-005242-41

HOPE (Haemorrhagic transformation risk Prediction and prevention in ischaemic stroke)

Principal Investigator: Dr Joan Martí Fàbregas

HOPE aims to better understand the risk of haemorrhagic transformation following ischaemic stroke and identify effective prevention strategies. The study integrates clinical, imaging, and biomarker data.

Status: Ongoing
ClinicalTrials.gov ID: NCT04892511

PhEAST-3 (Pharyngeal electrical stimulation for dysphagia after stroke)

PI: Professor Philip M Bath, University of Nottingham – UK
ethics applications are underway; aim for first patient is Oct/Nov 2023 (Status: August 2023)

REvive (A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke)

REvive is a multinational, Phase 2b, randomized, double-blind clinical trial evaluating the efficacy and safety of redasemtide (S-005151) in adult patients with acute ischemic stroke (AIS) who are not eligible for thrombolysis or mechanical thrombectomy. The study aims to determine whether redasemtide can improve functional outcomes in this patient population.

The trial plans to enroll approximately 627 participants across multiple countries, including Australia, Belgium, China, Czechia, Denmark, Finland, Germany, Greece, and other.

Status: Recruiting (as of March 2025)
ClinicalTrials.gov ID: NCT05953480

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

TECNO (Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusions)

PI: Steering Committee

TECNO is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) trial utilizing an adaptive statistical design comparing the rates of early and late reperfusion in patients with incomplete mechanical thrombectomy treated either by IA TNK or by best medical treatment BMT. This trial has two balanced treatment arms, with the IA TNK being the experimental arm. The standard arm is defined as BMT after incomplete MT. 156 patients will be randomly assigned to either the standard or the experimental arm with a ratio of 1:1 (78 patients per group).

About The Trial

Trials in planning phase collaborating with ESOTA networks

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)