Status:
ACTIVE_NOT_RECRUITING
OPTIMAS: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke : a Randomised Controlled Trial
Lead Sponsor:
University College, London
Conditions:
Stroke, Acute
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 anticoagulati...
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 arbitrar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
3648 Patients enrolled
Trial Details
Trial ID
NCT03759938
Start Date
June 18 2019
End Date
October 31 2024
Last Update
May 14 2024
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Bronglais General Hospital, Hywel Dda University Health Board
Aberystwyth, United Kingdom, SY23 1ER
2
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom, BA1 3NG
3
Queen Elizabeth Hospital,University Hospitals Birmingham NHS Foundation
Birmingham, United Kingdom, B15 2TH
4
Royal Bournemouth Hospital, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, United Kingdom, BH7 7DW