ELAN
Research type
Research Study
Full title
Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial
IRAS ID
230286
Contact name
Jesse Dawson
Contact email
Sponsor organisation
Inselspital (University Hospital) Bern
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Atrial fibrillation is the most common cause type of heart rhythm disturbance (also called an ‘irregular heartbeat’ or ‘AF’). It increases risk of blood clots in the heart, which can travel to the brain and cause stroke. This causes approximately 1/4 of ischaemic strokes. After an AF related stroke there is a risk of second stroke. This risk is highest in the next 30 days. We prevent these strokes using drugs called anticoagulants, powerful blood thinning drugs. They are very effective but can cause bleeding, including into the brain. Warfarin is an example but there are now newer drugs, which cause less brain bleeding, called direct oral anticoagulants (or DOACs).
After an ischaemic stroke there is a risk of brain bleeding even without blood thinning drugs. Patients with recent stroke were typically excluded from trials of blood thinning drugs for this reason. This means doctors don't know when to start these drugs and our current practice is to wait a period of days to several weeks. This might be safe in terms of reducing bleeding risk, but also leaves patients at risk of further ischaemic strokes.
We want to assess the best time to start these drugs. We hypothesise that early initiation of anticoagulant drugs will be as safe as later initiation and that it will lead to fewer recurrent strokes. Importantly, we are using the newer anticoagulant drugs, which we know to cause less brain bleeding in patients without stroke as we expect this to be the safest approach.
The ELAN trial is an international clinical trial investigating the safety and efficacy of early treatment with anticoagulants in ischaemic stroke patients with AF. We will include 2000 participants who will be randomised to early or later initiation of DOACs and will be followed for 90 days.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0092
Date of REC Opinion
1 May 2018
REC opinion
Further Information Favourable Opinion