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

ConditionsIschemic StrokeAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

This study evaluates the safety and efficacy of early versus delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischemic stroke related to atrial fibrillation who develop hemorrhagic transformation after endovascular treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

12-lead ECG recording;

Disqualifiers

Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).

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) ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early anticoagulation

    Drug

    Early initiation of direct oral anticoagulants will be started within 4 weeks after symptom onset.

  • Delayed anticoagulation

    Drug

    Delayed initiation of direct oral anticoagulants will be started between 4-8 weeks after symptom onset.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Early anticoagulationActive comparator 1 intervention
Group B: Delayed anticoagulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death

Time frame
90 days

Secondary outcomes

1

Incidence of recurrent ischemic stroke

Time frame
90 days and 1 year
2

Incidence of venous thromboembolism

Time frame
90 days
3

Incidence of systemic embolism

Time frame
90 days
4

Incidence of myocardial infarction

Time frame
90 days

Other outcomes

1

Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov
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