OPTIMAS Trial
Research type
Research Study
Full title
OPtimal TIMing of Anticoagulation after acute ischaemic Stroke: a randomised controlled trial (OPTIMAS Trial)
IRAS ID
249552
Contact name
David Werring
Contact email
Sponsor organisation
Comprehensive Clinical Trials Unit, University College London
Eudract number
2018-003859-38
ISRCTN Number
ISRCTN17896007
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UKCRN, 40836
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Atrial fibrillation (AF) is a type of irregular heartbeat that can cause blood clots to form in the heart. The movement of these clots can block blood vessels in the brain, causing a type of stroke known as a cardioembolic ischaemic stroke. Direct oral anticoagulants (DOACs) are medicines prescribed to prevent further strokes in people with AF who have had a stroke, and are usually started 7-14 days after stroke as standard care. However, it is unclear if starting DOAC treatment earlier than standard care could benefit patients; early treatment (up to 4 days after stroke) may lower the risk of further stroke, but may increase the risk of major bleeding, especially in the brain.
This trial aims to compare the effectiveness of early DOAC treatment to prevent recurrent stroke and systemic embolism (i.e. a blood clot in an artery) in patients with acute ischaemic stroke and AF with that of standard timing of DOAC treatment. The four DOACs that are usually prescribed to prevent recurrent stroke are dabigatran, apixaban, rivaroxaban, edoxaban, and they will be used according to their drug licenses in this trial. The choice of DOAC will be decided by the treating doctor, but the timing of treatment will be allocated to either early or standard. It is expected that 3500 adult patients (≥18 years) admitted to +100 participating acute stroke units with acute ischaemic stroke and AF will be screened for eligibility, and consented (by patient or legal representative if the patient is too unwell to make their own decisions). They will then be entered into the trial receive early or standard DOAC treatment. Patients who cannot have anticoagulant treatment because of specific conditions such as an increased tendency to bleed or poor liver function will be excluded.Participants will be followed up at 90 days post-study entry to collect information on how well they have taken DOAC treatment (known as adherence), side effects, and whether they have had specific clinical events such as stroke, bleeding, and systemic embolism. This information will allow the researchers to calculate the rate of newly-occurring stroke, bleeding in the brain (symptomatic intracranial haemorrhage), and systemic embolism in the 90 day treatment period for each of the two groups (early and standard) so they can be compared. The impact of early versus standard treatment on participants’ quality of life and cognition will also be investigated by using specific assessments.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0021
Date of REC Opinion
14 Mar 2019
REC opinion
Further Information Favourable Opinion