Last updated on December 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cerebrovascular accident | Atrial Fibrillation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Aged 18 years or over
  2. Clinical diagnosis of acute ischaemic stroke
  3. AF, confirmed by any of:
  4. 12-lead ECG recording
  5. Inpatient ECG telemetry
  6. Other prolonged ECG monitoring technique (e.g. Holter monitor)
  7. Known diagnosis of atrial fibrillation verified by medical records (e.g. primary care records, letter from secondary care)
  8. Eligibility to commence DOAC in accordance with approved prescribing recommendations confirmed by treating physician
  9. Uncertainty on the part of the treating physician regarding early versus standard initiation of DOAC.

Exclusion Criteria:

  1. Contraindication to anticoagulation:
  2. Coagulopathy or current or recent anticoagulation with vitamin K antagonist (VKA) leading to INR 1.7 at randomisation.
  3. Thrombocytopenia (platelets < 75 x 10/L)
  4. Other coagulopathy or bleeding tendency (based on clinical history or laboratory parameters) judged to contraindicate anticoagulation by treating clinician
  5. Contraindication to early anticoagulation
  6. 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)
  7. Presence of clinically significant intracranial haemorrhage unrelated to qualifying infarct
  8. Any other contraindication to early anticoagulation as judged by the treating clinician
  9. Contraindication to use of DOAC:
  10. Known allergy or intolerance to both Factor Xa inhibitor and direct thrombin inhibitor
  11. Definite indication for VKA treatment e.g. mechanical heart valve, valvular AF, antiphospholipid syndrome
  12. Severe renal impairment with creatinine clearance (Cockcroft & Gault formula) <15 mL/min (i.e. 14 mL/min or less)
  13. Liver function tests ALT > 2x ULN
  14. Cirrhotic patients with Child Pugh score equating to grade B or C
  15. 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
  16. Pregnant or breastfeeding women
  17. Presence on acute brain imaging of non-stroke pathology judged likely to explain clinical presentation (e.g. mass lesion, encephalitis)
  18. Inability for patient to be followed up within 90 days of trial entry
  19. Patient or representative refusal to consent to study procedures, including the site informing GP and healthcare professional responsible for anticoagulation care of participants
  20. 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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