Ischemic Stroke
Conditions
Interventions
Early anticoagulation:Early initiation of any direct oral anticoagulant (DOAC) within 96 hours (4 days) of the onset of acute ischemic stroke
Delayed anticoagulation:Delayed initiation of any direct oral anticoagulant (DOAC) between 5-14 days 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: a. 12-lead ECG recording b. Inpatient ECG telemetry c. Prolonged ECG monitoring (e.g. Holter monitor) d. Previously established diagnosis of atrial fibrillation verified by medical records. 5.CT or MRI demonstrating one of the following findings: a. No hemorrhagic transformation; b. Hemorrhagic infarction type 1 (HI1), defined as small petechiae along the margins of the infarct (Heidelberg classification); c. Hemorrhagic infarction type 2 (HI2), defined as confluent petechiae within the infarcted area without space-occupying effect (Heidelberg classification). 6.Time from stroke onset to randomization was within 72 hours. 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): a. Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors; b. Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation); c. 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) ; d. Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers; e. 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 systemic embolism;Proportion of Patients Achieving mRS 0–1 at 90 Days;Proportion of Patients Achieving mRS 0–2 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