OPTIMAS: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke : a Randomised Controlled Trial
NCT ID: NCT03759938
Last Updated: 2024-05-14
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
3648 participants
INTERVENTIONAL
2019-06-18
2024-10-31
Brief Summary
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Detailed Description
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OPTIMAS will investigate whether early initiation of DOAC treatment, within 4 days (96hrs) of onset, in patients with acute ischaemic stroke and AF is as effective as, or better than, standard initiation of DOAC treatment, no sooner than day 7 (\>144hrs) and no later than day 14 (\<336hrs) after onset, in preventing recurrent ischaemic stroke, systemic embolism and symptomatic intracranial haemorrhage (sICH)? Participants will be randomised 1:1 to the intervention or control. The exact timing of initiating treatment within each group is at the discretion of the treating clinician.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
This group consists of a panel of experts who have the relevant therapeutic area expertise, are experienced in clinical trials, and have been trained on the specific study protocol.
The Event Adjudication Committee will centrally review events reported using all available clinical and imaging data and evaluate efficacy and/ or safety endpoints in a blinded and unbiased manner on a regular basis to ensure accurate, consistent and standardized assessments of important study events such as recurrent symptomatic ischaemic stroke, systemic embolism and death.
Study Groups
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Early initiation of DOAC
Early initiation of any direct oral anticoagulant (DOAC) at a dose licensed for stroke prevention in AF, within four days (96hrs) of onset of acute ischaemic stroke
Direct oral anticoagulant (DOAC)
Any of the DOACs listed above may be used for treatment in either study arm. The DOAC will be supplied from normal hospital stock, using local hospital prescriptions.
Standard Initiation of DOAC
Standard initiation of any DOAC at a dose licensed for stroke prevention in AF, no sooner than day 7 and no later than day 14 after the onset of acute ischaemic stroke (i.e. between 144hrs and 336hrs from onset).
Direct oral anticoagulant (DOAC)
Any of the DOACs listed above may be used for treatment in either study arm. The DOAC will be supplied from normal hospital stock, using local hospital prescriptions.
Interventions
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Direct oral anticoagulant (DOAC)
Any of the DOACs listed above may be used for treatment in either study arm. The DOAC will be supplied from normal hospital stock, using local hospital prescriptions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of acute ischaemic stroke
3. AF, confirmed by any of:
1. 12-lead ECG recording
2. Inpatient ECG telemetry
3. Other prolonged ECG monitoring technique (e.g. Holter monitor)
4. Known diagnosis of atrial fibrillation verified by medical records (e.g. primary care records, letter from secondary care)
4. Eligibility to commence DOAC in accordance with approved prescribing recommendations confirmed by treating physician
5. Uncertainty on the part of the treating physician regarding early versus standard initiation of DOAC.
Exclusion Criteria
1. Coagulopathy or current or recent anticoagulation with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomisation.
2. Thrombocytopenia (platelets \< 75 x 10⁹/L)
3. Other coagulopathy or bleeding tendency (based on clinical history or laboratory parameters) judged to contraindicate anticoagulation by treating clinician
2. Contraindication to early anticoagulation
1. Known presence of haemorrhagic transformation with parenchymal haematoma occupying \>30% of the infarct volume and exerting significant mass effect (i.e. PH2) (NB: HI1, HI2 and PH1 are not considered contraindications)
2. Presence of clinically significant intracranial haemorrhage unrelated to qualifying infarct
3. Any other contraindication to early anticoagulation as judged by the treating clinician
3. Contraindication to use of DOAC:
1. Known allergy or intolerance to both Factor Xa inhibitor and direct thrombin inhibitor
2. Definite indication for VKA treatment e.g. mechanical heart valve, valvular AF, antiphospholipid syndrome
3. Severe renal impairment with creatinine clearance (Cockcroft \& Gault formula) \<15 mL/min (i.e. 14 mL/min or less)
4. Liver function tests ALT \> 2x ULN
5. Cirrhotic patients with Child Pugh score equating to grade B or C
6. Patient is taking medication with significant interaction with DOAC, including:
* Azole antifungals (e.g. ketoconazole, itraconazole)
* HIV protease inhibitors (e.g. ritonavir)
* Strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort)
* Dronedarone
4. Pregnant or breastfeeding women
5. Presence on acute brain imaging of non-stroke pathology judged likely to explain clinical presentation (e.g. mass lesion, encephalitis)
6. Inability for patient to be followed up within 90 days of trial entry
7. Patient or representative refusal to consent to study procedures, including the site informing GP and healthcare professional responsible for anticoagulation care of participants
8. Any other reason that the PI considers would make the patient unsuitable to enter OPTIMAS.
Note that current DOAC treatment is NOT an exclusion criterion, as long as the treating physician considers it appropriate to restart (or continue) according to the timings specified in the OPTIMAS trial protocol. Continuation of the DOAC would be recorded as a start time of zero hours.
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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David Werring, Prof
Role: STUDY_CHAIR
UCL
Locations
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Bronglais General Hospital, Hywel Dda University Health Board
Aberystwyth, , United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, , United Kingdom
Queen Elizabeth Hospital,University Hospitals Birmingham NHS Foundation
Birmingham, , United Kingdom
Royal Bournemouth Hospital, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, , United Kingdom
Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Foundation Trust
Bradford, , United Kingdom
Broomfield Hospital, Mid Essex Hospital Services NHS Trust
Broomfield, , United Kingdom
West Suffolk Hospital, West Suffolk NHS Foundation Trust
Bury St Edmunds, , United Kingdom
Addenbrooke's Hospital NHS Trust
Cambridge, , United Kingdom
Glangwili General Hospita, Hywel Dda University Health Boardl
Carmarthen, , United Kingdom
St Peter's Hospital, Ashford and St. Peter's Hospitals NHS Foundation Trust
Chertsey, , United Kingdom
Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
Derby, , United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, , United Kingdom
Withybush General Hospital, Hywel Dda University Health Board
Haverfordwest, , United Kingdom
Wycombe Hospital, Buckinghamshire Healthcare NHS Trust
High Wycombe, , United Kingdom
Queen Elizabeth Hospital Kings Lynn NHS Trust
Kings Lynn, , United Kingdom
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, , United Kingdom
Prince Philip Hospital, Hywel Dda University Health Board
Llanelli, , United Kingdom
The Royal London Hospital, Barts Health NHS Trust
London, , United Kingdom
Northwick Park Hospital, London North West Healthcare NHS Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, , United Kingdom
Luton and Dunstable University Hospital NHS Foundation Trust
Luton, , United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Derriford Hospital University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Poole Hospital NHS Foundation Trust
Poole, , United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals
Preston, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Salford Royal Hospital, Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Salisbury District Hospital, Salisbury NHS Foundation Trust
Salisbury, , United Kingdom
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, , United Kingdom
Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, , United Kingdom
Morriston Hospital, Swansea Bay University Health Board
Swansea, , United Kingdom
Torbay Hospital, Torbay and South Devon NHS Foundation
Torquay, , United Kingdom
Arrowe Park Hospital, Wirral University Teaching Hospital NHS Foundation Trust
Upton, , United Kingdom
Watford General Hospital, West Hertfordshire Hospitals NHS Trust
Watford, , United Kingdom
Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust
Winchester, , United Kingdom
Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
Wrexham, , United Kingdom
York Teaching Hospital NHS Foundation Trust
York, , United Kingdom
Countries
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References
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Nash PS, Dehbi HM, Ahmed N, Arram L, Best JG, Balogun M, Bennett K, Bordea E, Caverly E, Chau M, Cohen H, Cullen M, Dore CJ, Engelter ST, Fenner R, Ford GA, Gill A, Hunter R, James M, Jayanthi A, Lip GYH, Massingham S, Murray ML, Mazurczak I, Ndoutoumou A, Norrving B, Philip J, Sims H, Sprigg N, Vanniyasingam T, Freemantle N, Wheeler DC, Werring DJ; OPTIMAS Investigators. Anticoagulation Timing in Acute Stroke With Atrial Fibrillation According to Chronic Kidney Disease: The OPTIMAS Trial. Stroke. 2025 Aug;56(8):1970-1979. doi: 10.1161/STROKEAHA.125.051457. Epub 2025 May 22.
Ahmed N, Dehbi HM, Freemantle N, Best J, Nash PS, Ruffle JK, Doig D, Werring DJ. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): statistical analysis plan for a randomised controlled trial. Trials. 2025 Feb 19;26(1):58. doi: 10.1186/s13063-025-08761-6.
Werring DJ, Dehbi HM, Ahmed N, Arram L, Best JG, Balogun M, Bennett K, Bordea E, Caverly E, Chau M, Cohen H, Cullen M, Dore CJ, Engelter ST, Fenner R, Ford GA, Gill A, Hunter R, James M, Jayanthi A, Lip GYH, Massingham S, Murray ML, Mazurczak I, Nash PS, Ndoutoumou A, Norrving B, Sims H, Sprigg N, Vanniyasingam T, Freemantle N; OPTIMAS investigators. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial. Lancet. 2024 Oct 23:S0140-6736(24)02197-4. doi: 10.1016/S0140-6736(24)02197-4. Online ahead of print.
Best JG, Arram L, Ahmed N, Balogun M, Bennett K, Bordea E, Campos MG, Caverly E, Chau M, Cohen H, Dehbi HM, Dore CJ, Engelter ST, Fenner R, Freemantle N, Hunter R, James M, Lip GY, Murray ML, Norrving B, Sprigg N, Veltkamp R, Zaczyk I, Werring DJ; OPTIMAS investigators. Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS): Protocol for a randomized controlled trial. Int J Stroke. 2022 Jun;17(5):583-589. doi: 10.1177/17474930211057722. Epub 2022 Jan 12.
Other Identifiers
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18/0316
Identifier Type: -
Identifier Source: org_study_id
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