ISRCTN17896007进行中（未招募）未知
OPtimal TIMing of Anticoagulation after acute ischaemic Stroke (OPTIMAS): a randomised controlled trial
niversity College London0 个研究点目标入组 3,478 人开始时间: 2019年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,478
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35018878/ (added 13/01/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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