Ischemic Stroke
Conditions
Interventions
Early anticoagulation:Early initiation of any direct oral anticoagulant (DOAC) within 4 weeks of the onset of acute ischemic stroke
Delayed anticoagulation:Delayed initiation of any direct oral anticoagulant (DOAC) between 4-8 weeks of the onset of acute ischemic stroke
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over; 2. Clinical diagnosis of large vessel occlusion acute ischemic stroke; 3. Emergency endovascular treatment was performed within 24 hours of stroke onset; 4. Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following: (1). 12-lead ECG recording; (2). Inpatient ECG telemetry; (3). Prolonged ECG monitoring (e.g. Holter monitor); (4). Previously established diagnosis of atrial fibrillation verified by medical records. 5. CT or MRI demonstrating one of the following findings: (1). Parenchymatous hematoma type 1: defined as hematoma occupying less than 30% of the infarcted tissue, no substantive mass effect (Heidelberg classification); (2). Parenchymatous hematoma type 2: defined as heamtoma occupying 30% or more of the infarcted tissue, with obvious mass effect (Heidelberg classification); (3). Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage (Heidelberg classification). 6. Time from stroke onset to randomization ranged from 7 days to 4 weeks; 7. Written informed consent obtained from the patient or a legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct); 2. Contraindication to the use of direct oral anticoagulants (DOACs): (1). Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors; (2). Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation); (3). Severe renal impairment (defined as creatinine exceeding 1.5 times of the upper limit of normal range) and significant hepatic dysfunction (defined as ALT or AST > twice the upper limit of normal range) ; (4). Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers; (5). Baseline platelet count =1.7 at randomization; 4. Pregnant or breastfeeding women, or positive pregnancy test at admission; 5. History of major surgery or severe trauma within 1 month prior to stroke onset; 6. History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding); 7. Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial; 8. Evidence of cerebral amyloid angiopathy; 9. CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis); 10. Modified Rankin scale (mRS) score > 1 prior to stroke onset; 11. Inability to complete the 90-day follow-up; 12. Currently participating in another drug clinical trial; 13. Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of recurrent ischemic stroke;Incidence of venous thromboembolism;Incidence of venous thromboembolism;Proportion of Patients Achieving mRS 0–2 at 90 Days;Proportion of Patients Achieving mRS 0–3 at 90 Days;Quality of life at 90 days assessed by EQ-5D-5L;Incidence of myocardial infarction;Length of hospital stay for stroke-related care;Incidence of vascular death;All-cause mortality;Incidence of symptomatic intracranial haemorrhage;Incidence of major extracranial bleeding; | — |
Countries
China
Contacts
Public ContactXunming Ji
Xuanwu Hospital, Capital Medical University
Outcome results
None listed