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ACTIVE NOT RECRUITING

NCT03759938

OPTIMAS: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke : a Randomised Controlled Trial

Sponsor: University College, London

View on ClinicalTrials.gov

Summary

OPTIMAS is a large, prospective, partially blinded randomised controlled trial of early (within ≤4 days \[96hrs\]) or standard (between day 7 and day 14 after stroke onset) initiation of anticoagulation after stroke in patients with atrial fibrillation (AF), using any licensed dose of a direct oral anticoagulant (DOAC). The trial will use a non-inferiority gatekeeper approach to test for non-inferiority of early anticoagulation followed by a test for superiority, if non-inferiority is established.

Official title: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3648

Start Date

2019-06-18

Completion Date

2024-10-31

Last Updated

2024-05-14

Healthy Volunteers

Conditions

Stroke, Acute Atrial Fibrillation

Interventions

DRUG

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.

Inclusion Criteria: 1. Aged 18 years or over 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. Contraindication to anticoagulation: 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.

Locations (44)

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

Clinical Research Directory

OPTIMAS: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke : a Randomised Controlled Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (44)