Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2

Korábbi kezelés

• History of major surgery or severe trauma within 1 month prior to stroke onset.
• History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding).
• Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial.
• Modified Rankin scale (mRS) score > 1 prior to stroke onset.
• Currently participating in another drug clinical trial.

Más betegség

• Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
• CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis).

Laborértékek

• Contraindication to the use of direct oral anticoagulants (DOACs):
  • Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;
  • Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);
  • 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) ;
  • Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;
  • Baseline platelet count < 100 x 109/L;
  • History of coagulopathy or systemic hemorrhage.
• Prior DOAC use within 48 hours of stroke onset, or recent treatment with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomization.

Egyéb

• Pregnant or breastfeeding women, or positive pregnancy test at admission.
• Evidence of cerebral amyloid angiopathy.
• Inability to complete the 90-day follow-up.
• Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.

• Aged 18 years or over.
• Clinical diagnosis of large vessel occlusion acute ischemic stroke.
• Emergency endovascular treatment was performed within 24 hours of stroke onset.
• Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:
  • 12-lead ECG recording;
  • Inpatient ECG telemetry;
  • Prolonged ECG monitoring (e.g. Holter monitor);
  • Previously established diagnosis of atrial fibrillation verified by medical records.
• CT or MRI demonstrating one of the following findings:
  • Parenchymatous hematoma type 1: defined as hematoma occupying less than 30% of the infarcted tissue, no substantive mass effect (Heidelberg classification);
  • Parenchymatous hematoma type 2: defined as heamtoma occupying 30% or more of the infarcted tissue, with obvious mass effect (Heidelberg classification);
  • Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage (Heidelberg classification).
• Time from stroke onset to randomization ranged from 7 days to 4 weeks.
• Written informed consent obtained from the patient or a legally authorized representative.