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

Primary Purpose

Stroke, Acute, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Direct oral anticoagulant (DOAC)
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring ischaemic stroke, atrial fibrilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bronglais General Hospital, Hywel Dda University Health BoardRecruiting
  • Royal United Hospitals Bath NHS Foundation TrustRecruiting
  • Queen Elizabeth Hospital,University Hospitals Birmingham NHS FoundationRecruiting
  • Royal Bournemouth Hospital, Royal Bournemouth and Christchurch Hospitals NHS Foundation TrustRecruiting
  • Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Foundation TrustRecruiting
  • Broomfield Hospital, Mid Essex Hospital Services NHS TrustRecruiting
  • West Suffolk Hospital, West Suffolk NHS Foundation TrustRecruiting
  • Addenbrooke's Hospital NHS TrustRecruiting
  • Glangwili General Hospita, Hywel Dda University Health BoardlRecruiting
  • St Peter's Hospital, Ashford and St. Peter's Hospitals NHS Foundation TrustRecruiting
  • Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation TrustRecruiting
  • Royal Devon & Exeter NHS Foundation TrustRecruiting
  • Withybush General Hospital, Hywel Dda University Health BoardRecruiting
  • Wycombe Hospital, Buckinghamshire Healthcare NHS TrustRecruiting
  • Queen Elizabeth Hospital Kings Lynn NHS TrustRecruiting
  • Leicester Royal Infirmary, University Hospitals of Leicester NHS TrustRecruiting
  • Royal Liverpool and Broadgreen University Hospitals NHS TrustRecruiting
  • Prince Philip Hospital, Hywel Dda University Health BoardRecruiting
  • The Royal London Hospital, Barts Health NHS TrustRecruiting
  • Northwick Park Hospital, London North West Healthcare NHS TrustRecruiting
  • University College London Hospitals NHS Foundation TrustRecruiting
  • St George's University Hospitals NHS Foundation TrustRecruiting
  • Charing Cross Hospital, Imperial College Healthcare NHS TrustRecruiting
  • Luton and Dunstable University Hospital NHS Foundation TrustRecruiting
  • The James Cook University Hospital, South Tees Hospitals NHS Foundation TrustRecruiting
  • Milton Keynes University Hospital NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting
  • Derriford Hospital University Hospitals Plymouth NHS TrustRecruiting
  • Poole Hospital NHS Foundation TrustRecruiting
  • Royal Preston Hospital, Lancashire Teaching HospitalsRecruiting
  • Royal Berkshire NHS Foundation TrustRecruiting
  • Salford Royal Hospital, Salford Royal NHS Foundation TrustRecruiting
  • Salisbury District Hospital, Salisbury NHS Foundation TrustRecruiting
  • Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
  • University Hospital Southampton NHS Foundation TrustRecruiting
  • Southend University Hospital NHS Foundation TrustRecruiting
  • Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation TrustRecruiting
  • Morriston Hospital, Swansea Bay University Health BoardRecruiting
  • Torbay Hospital, Torbay and South Devon NHS FoundationRecruiting
  • Arrowe Park Hospital, Wirral University Teaching Hospital NHS Foundation TrustRecruiting
  • Watford General Hospital, West Hertfordshire Hospitals NHS TrustRecruiting
  • Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation TrustRecruiting
  • Wrexham Maelor Hospital, Betsi Cadwaladr University Health BoardRecruiting
  • York Teaching Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early initiation of DOAC

Standard Initiation of DOAC

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Composite outcome of the combined incidence of:recurrent symptomatic ischaemic stroke,symptomatic intracranial haemorrhage and systemic embolism
OPTIMAS will investigate whether early initiation of DOAC treatment in patients with acute ischaemic stroke and atrial fibrillation is as effective as, or better than, standard initiation of DOAC treatment in preventing recurrent ischaemic stroke, systemic embolism and sICH.

Secondary Outcome Measures

All-cause mortality
All cause mortality reported in both arms
Incidence of vascular death
Any incidence of vascular death reported in both arms
Incidence of recurrent ischaemic stroke
Any incidence of recurrent ischaemic stroke reported in both arms
Incidence of systemic embolism
Any incidence of incidence of systemic embolism reported in both arms
Incidence of venous thromboembolism (deep vein thrombosis [DVT], pulmonary embolism [PE], cerebral venous thrombosis [CVT])
Any of Incidence of venous thromboembolism (deep vein thrombosis [DVT], pulmonary embolism [PE], cerebral venous thrombosis [CVT]) reported in both arms
Functional status assessed by the modified Rankin scale (mRS) in both arms
The Modified Rankin Scale measures the degree of disability and dependence following a stroke. The scale consists of 7 category descriptions, where 0 means no symptoms, 1 means no significant disability, 2 means slight disability, 3 means moderate disability, 4 means moderately severe disability, 5 means severe disability and 6 means death. The assessment is carried out by asking the participant or their carer about their activities of daily living.
Cognitive ability assessed by the Montreal Cognitive Assessment (MoCA) questionnaire in both arms
The Montreal Cognitive Assessment is a questionnaire widely used as a screening assessment for detecting cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. An abbreviated version of the MoCA assessing attention, verbal learning, memory, executive functions/language and orientation can be performed over the phone. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study and people with mild cognitive impairment (MCI) scored an average of 22.1.
Quality of life at 90 days assessed by EuroQol 5 Dimensions 5 level questionnaire [EQ-5D-5L] in both arms
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. In instances in which the participant struggles with giving answers on their own, the participant's next-of-kin or a friend who knows the participant well will be asked to complete the EQ-5D-5L proxy version. The proxy is asked to rate how they think the participant would rate their own health-related quality of life, if the participant were able to communicate it. In case a proxy is not available, the research team member who was looking after the participant will complete it on their behalf.
Patient reported outcomes assessed by the Patient-Reported Outcomes Measurement Information System Global Health questionnaire (PROMIS-10) in both arms.
The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The scoring system of the PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health where 0 means never experienced this problem or symptoms and 1 means always. The higher score for each response indicate better health.
Ongoing anticoagulation
Ongoing anticoagulation will be assessed based on patient self-reporting and follow up patient medical records if necessary in both arms
Time to first incidence of primary outcome component (recurrent ischaemic stroke, systemic embolism, or sICH)
Time to first incidence of primary outcome component (recurrent ischaemic stroke, systemic embolism, or sICH) reported in both arms
Length of hospital stay for stroke-related care
Length of hospital stay for stroke-related care in both arms
Health and social care resource use
Health and social care resources (assessed by a study specific questionnaire) in both arms
Incidence of symptomatic intracranial haemorrhage (sICH)
Incidence of symptomatic intracranial haemorrhage (sICH) classified according to site intracerebral haemorrhage (within the brain parenchyma); subdural haemorrhage; extradural haemorrhage; subarachnoid haemorrhage; and haemorrhagic transformation of a brain infarct, in both arms
Incidence of major extracranial bleeding
Incidence of major extracranial bleeding reported in both arms
Incidence of all major bleeding (intracranial and extracranial)
Incidence of all major bleeding (intracranial and extracranial) reported during the study period, in both arms
Incidence of clinically relevant non-major bleeding
Incidence of clinically relevant non-major bleeding reported in both arms

Full Information

First Posted
November 27, 2018
Last Updated
March 14, 2023
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03759938
Brief Title
OPTIMAS: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke : a Randomised Controlled Trial
Acronym
OPTIMAS
Official Title
OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Current guidelines do not provide clear recommendations on the timing of OAC after acute AF-related stroke. Current United Kingdom (UK) guidelines for anticoagulation state that "delay for an arbitrary 2-week period is recommended" for "disabling" stroke and that anticoagulation can be started "no later than 14 days" for other strokes, at the prescriber's discretion. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Atrial Fibrillation
Keywords
ischaemic stroke, atrial fibrilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised in a 1:1 ratio to intervention or control arms of the study. Participants and their physicians will not be blinded to study arm allocation.The exact timing of anticoagulation within the period specified for the allocated study arm is at the discretion of the treating physician, as is the choice of DOAC. Apart from the timing of DOAC initiation, the DOAC should be prescribed in accordance with usual clinical practice
Masking
Outcomes Assessor
Masking Description
The Event Adjudication Committee is a study group (of at least three members) responsible for the review of clinical events to ensure consistent, standardized, objective and unbiased results throughout all participating sites and minimise the likelihood of discrepant interpretations. 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.
Allocation
Randomized
Enrollment
3478 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early initiation of DOAC
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Initiation of DOAC
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Direct oral anticoagulant (DOAC)
Other Intervention Name(s)
dabigatran, apixaban, edoxaban, rivaroxaban
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite outcome of the combined incidence of:recurrent symptomatic ischaemic stroke,symptomatic intracranial haemorrhage and systemic embolism
Description
OPTIMAS will investigate whether early initiation of DOAC treatment in patients with acute ischaemic stroke and atrial fibrillation is as effective as, or better than, standard initiation of DOAC treatment in preventing recurrent ischaemic stroke, systemic embolism and sICH.
Time Frame
At 90 days from randomisation
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All cause mortality reported in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of vascular death
Description
Any incidence of vascular death reported in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of recurrent ischaemic stroke
Description
Any incidence of recurrent ischaemic stroke reported in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of systemic embolism
Description
Any incidence of incidence of systemic embolism reported in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of venous thromboembolism (deep vein thrombosis [DVT], pulmonary embolism [PE], cerebral venous thrombosis [CVT])
Description
Any of Incidence of venous thromboembolism (deep vein thrombosis [DVT], pulmonary embolism [PE], cerebral venous thrombosis [CVT]) reported in both arms
Time Frame
At 90 days from randomisation
Title
Functional status assessed by the modified Rankin scale (mRS) in both arms
Description
The Modified Rankin Scale measures the degree of disability and dependence following a stroke. The scale consists of 7 category descriptions, where 0 means no symptoms, 1 means no significant disability, 2 means slight disability, 3 means moderate disability, 4 means moderately severe disability, 5 means severe disability and 6 means death. The assessment is carried out by asking the participant or their carer about their activities of daily living.
Time Frame
At 90 days from randomisation
Title
Cognitive ability assessed by the Montreal Cognitive Assessment (MoCA) questionnaire in both arms
Description
The Montreal Cognitive Assessment is a questionnaire widely used as a screening assessment for detecting cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. An abbreviated version of the MoCA assessing attention, verbal learning, memory, executive functions/language and orientation can be performed over the phone. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study and people with mild cognitive impairment (MCI) scored an average of 22.1.
Time Frame
At 90 days from randomisation
Title
Quality of life at 90 days assessed by EuroQol 5 Dimensions 5 level questionnaire [EQ-5D-5L] in both arms
Description
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. In instances in which the participant struggles with giving answers on their own, the participant's next-of-kin or a friend who knows the participant well will be asked to complete the EQ-5D-5L proxy version. The proxy is asked to rate how they think the participant would rate their own health-related quality of life, if the participant were able to communicate it. In case a proxy is not available, the research team member who was looking after the participant will complete it on their behalf.
Time Frame
At 90 days from randomisation
Title
Patient reported outcomes assessed by the Patient-Reported Outcomes Measurement Information System Global Health questionnaire (PROMIS-10) in both arms.
Description
The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The scoring system of the PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health where 0 means never experienced this problem or symptoms and 1 means always. The higher score for each response indicate better health.
Time Frame
At 90 days from randomisation
Title
Ongoing anticoagulation
Description
Ongoing anticoagulation will be assessed based on patient self-reporting and follow up patient medical records if necessary in both arms
Time Frame
At 90 days from randomisation
Title
Time to first incidence of primary outcome component (recurrent ischaemic stroke, systemic embolism, or sICH)
Description
Time to first incidence of primary outcome component (recurrent ischaemic stroke, systemic embolism, or sICH) reported in both arms
Time Frame
At 90 days from randomisation
Title
Length of hospital stay for stroke-related care
Description
Length of hospital stay for stroke-related care in both arms
Time Frame
At 90 days from randomisation
Title
Health and social care resource use
Description
Health and social care resources (assessed by a study specific questionnaire) in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of symptomatic intracranial haemorrhage (sICH)
Description
Incidence of symptomatic intracranial haemorrhage (sICH) classified according to site intracerebral haemorrhage (within the brain parenchyma); subdural haemorrhage; extradural haemorrhage; subarachnoid haemorrhage; and haemorrhagic transformation of a brain infarct, in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of major extracranial bleeding
Description
Incidence of major extracranial bleeding reported in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of all major bleeding (intracranial and extracranial)
Description
Incidence of all major bleeding (intracranial and extracranial) reported during the study period, in both arms
Time Frame
At 90 days from randomisation
Title
Incidence of clinically relevant non-major bleeding
Description
Incidence of clinically relevant non-major bleeding reported in both arms
Time Frame
At 90 days from randomisation
Other Pre-specified Outcome Measures:
Title
Ongoing anticoagulation at 90 days
Description
Ongoing anticoagulation at 90 days assessed by patient self-reporting and/ or follow up patient medical records if necessary.
Time Frame
At 90 days from randomisation
Title
Individual cognitive domain subscores
Description
Individual cognitive domain subscores measured using the MoCA questionnaire
Time Frame
At 90 days from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or over Clinical diagnosis of acute ischaemic stroke AF, confirmed by any of: 12-lead ECG recording Inpatient ECG telemetry Other prolonged ECG monitoring technique (e.g. Holter monitor) Known diagnosis of atrial fibrillation verified by medical records (e.g. primary care records, letter from secondary care) Eligibility to commence DOAC in accordance with approved prescribing recommendations confirmed by treating physician Uncertainty on the part of the treating physician regarding early versus standard initiation of DOAC. Exclusion Criteria: Contraindication to anticoagulation: Coagulopathy or current or recent anticoagulation with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomisation. Thrombocytopenia (platelets < 75 x 10⁹/L) Other coagulopathy or bleeding tendency (based on clinical history or laboratory parameters) judged to contraindicate anticoagulation by treating clinician Contraindication to early anticoagulation 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) Presence of clinically significant intracranial haemorrhage unrelated to qualifying infarct Any other contraindication to early anticoagulation as judged by the treating clinician Contraindication to use of DOAC: Known allergy or intolerance to both Factor Xa inhibitor and direct thrombin inhibitor Definite indication for VKA treatment e.g. mechanical heart valve, valvular AF, antiphospholipid syndrome Severe renal impairment with creatinine clearance (Cockcroft & Gault formula) <15 mL/min (i.e. 14 mL/min or less) Liver function tests ALT > 2x ULN Cirrhotic patients with Child Pugh score equating to grade B or C 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 Pregnant or breastfeeding women Presence on acute brain imaging of non-stroke pathology judged likely to explain clinical presentation (e.g. mass lesion, encephalitis) Inability for patient to be followed up within 90 days of trial entry Patient or representative refusal to consent to study procedures, including the site informing GP and healthcare professional responsible for anticoagulation care of participants 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa Chau
Phone
+44 20 7670 4618
Ext
64618
Email
ctu.optimas@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Werring, Prof
Organizational Affiliation
UCL
Official's Role
Study Chair
Facility Information:
Facility Name
Bronglais General Hospital, Hywel Dda University Health Board
City
Aberystwyth
ZIP/Postal Code
SY23 1ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phil Jones
Facility Name
Royal United Hospitals Bath NHS Foundation Trust
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukuman Gbadamoshi
Facility Name
Queen Elizabeth Hospital,University Hospitals Birmingham NHS Foundation
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dom Sims
Facility Name
Royal Bournemouth Hospital, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamy Thavanesan
Facility Name
Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Foundation Trust
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Maguire
Facility Name
Broomfield Hospital, Mid Essex Hospital Services NHS Trust
City
Broomfield
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madan Meegada
Facility Name
West Suffolk Hospital, West Suffolk NHS Foundation Trust
City
Bury Saint Edmunds
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abul Azim
Facility Name
Addenbrooke's Hospital NHS Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eoin O'Brien
Facility Name
Glangwili General Hospita, Hywel Dda University Health Boardl
City
Carmarthen
ZIP/Postal Code
SA31 2AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pagadala Sridhar
Facility Name
St Peter's Hospital, Ashford and St. Peter's Hospitals NHS Foundation Trust
City
Chertsey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giosue Gulli
Facility Name
Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim England
Facility Name
Royal Devon & Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin James
Facility Name
Withybush General Hospital, Hywel Dda University Health Board
City
Haverfordwest
ZIP/Postal Code
SA61 2PZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher James
Facility Name
Wycombe Hospital, Buckinghamshire Healthcare NHS Trust
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Tuna
Facility Name
Queen Elizabeth Hospital Kings Lynn NHS Trust
City
King's Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Shekhar
Facility Name
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eveson David
Facility Name
Royal Liverpool and Broadgreen University Hospitals NHS Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aravind Manoj
Facility Name
Prince Philip Hospital, Hywel Dda University Health Board
City
Llanelli
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senthil Subbarayan
Facility Name
The Royal London Hospital, Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sageet Amlani
Facility Name
Northwick Park Hospital, London North West Healthcare NHS Trust
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumanjit Gill
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Werring
Phone
020 3108 6255
Email
d.werring@ucl.ac.uk
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Zhang
Facility Name
Charing Cross Hospital, Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soma Banerjee
Facility Name
Luton and Dunstable University Hospital NHS Foundation Trust
City
Luton
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lakshmanan Sekaran
Facility Name
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samer Al Hussayni
Facility Name
Milton Keynes University Hospital NHS Foundation Trust
City
Milton Keynes
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousif Behnam
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashit Shetty
Facility Name
Derriford Hospital University Hospitals Plymouth NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Shah
Facility Name
Poole Hospital NHS Foundation Trust
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Ragab
Facility Name
Royal Preston Hospital, Lancashire Teaching Hospitals
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hedley Emsley
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagaratnam Kirubanathan
Facility Name
Salford Royal Hospital, Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Kishore
Facility Name
Salisbury District Hospital, Salisbury NHS Foundation Trust
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toby Black
Facility Name
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsty Harkness
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Marigold
Facility Name
Southend University Hospital NHS Foundation Trust
City
Southend-on-Sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Guyler
Facility Name
Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
City
Sutton in Ashfield
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Cooper
Facility Name
Morriston Hospital, Swansea Bay University Health Board
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manju Krishnan
Facility Name
Torbay Hospital, Torbay and South Devon NHS Foundation
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John France
Facility Name
Arrowe Park Hospital, Wirral University Teaching Hospital NHS Foundation Trust
City
Upton
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Menezes
Facility Name
Watford General Hospital, West Hertfordshire Hospitals NHS Trust
City
Watford
ZIP/Postal Code
WD18 0HB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari
Facility Name
Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust
City
Winchester
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Sykes
Facility Name
Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
City
Wrexham
ZIP/Postal Code
LL 13 7TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walee Sayed
Facility Name
York Teaching Hospital NHS Foundation Trust
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruhail Mir

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35018878
Citation
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.
Results Reference
derived

Learn more about this trial

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

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