Optimal timing of anticoagulation after acute ischaemic stroke

Not Applicable

• Conditions: Acute ischaemic stroke with atrial fibrillation; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN17896007
• Lead Sponsor: niversity College London

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35018878/ (added 13/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 27 March 2023
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3478

Inclusion Criteria

1. Aged 18 years or over
2. Clinical diagnosis of acute ischaemic stroke
3. Atrial fibrillation, confirmed by any of:
3.1. 12-lead ECG recording
3.2. Inpatient ECG telemetry
3.3. Other prolonged ECG monitoring technique (e.g. Holter monitor)
3.4. 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:
1.1. Coagulopathy or current or recent anticoagulation with vitamin K antagonist (VKA) leading to INR > = 1.7 at randomisation.
1.2. Thrombocytopenia (platelets < 75 x 10^9/L)
1.3. Other coagulopathy or bleeding tendency (based on clinical history or laboratory parameters) judged to contraindicate anticoagulation by treating clinician
2. Contraindication to early anticoagulation
2.1. 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)
2.2. Presence of clinically significant intracranial haemorrhage unrelated to qualifying infarct
2.3. Any other contraindication to early anticoagulation as judged by the treating clinician
3. Contraindication to use of DOAC:
3.1. Known allergy or intolerance to both FXa inhibitor and direct thrombin inhibitor
3.2. Definite indication for VKA treatment e.g. mechanical heart valve, valvular AF, antiphospholipid syndrome
3.3. Severe renal impairment with creatinine clearance (Cockcroft & Gault formula) < 15 mL/min (i.e. 14 mL/min or less)
3.4. Liver function tests ALT > 2x ULN
3.5. Cirrhotic patients with Child Pugh score equating to grade B or C
3.6. Patient is taking medication with significant interaction with DOAC, including:
3.6.1. Azole antifungals (e.g. ketoconazole, itraconazole)
3.6.2. HIV protease inhibitors (e.g. ritonavir)
3.6.3. Strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort)
3.6.4. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified