Early Anticoagulation Therapy After Endovascular Treatment for Acute Ischemic Stroke With Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHao Yonggang
About this trial
The goal of this clinical trial is to learn whether starting a direct oral anticoagulant (DOAC) early after endovascular treatment works to improve outcomes in patients with ischemic stroke related to atrial fibrillation. It will also learn about the safety of early DOAC treatment. The main question it aims to answer is:
\- Does starting DOAC treatment 24 hours after endovascular treatment improve outcomes at 3 months compared with starting it 5 days after randomization?
Researchers will compare early DOAC treatment (started 24 hours after the procedure) with delayed DOAC treatment (started 5 days after randomization) to see if early treatment works better.
Participants will:
* Have atrial fibrillation-related acute ischemic stroke caused by a large vessel blockage in the front part of the brain, within 24 hours of symptom onset * Be randomly assigned to one of two groups after endovascular treatment: early DOAC treatment or delayed DOAC treatment * Take DOACs starting 24 hours after the procedure (early group) or 5 days after randomization (delayed group) * Be followed up for 3 months to check their recovery and any medical problems
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Symptom onset within 24 hours before enrollment.
A confirmed diagnosis of acute anterior circulation ischemic stroke.
A baseline NIHSS score ≥6 at admission.
Disqualifiers
Pre-stroke modified Rankin Scale (mRS) score >2.
Valvular atrial fibrillation.
Known hypersensitivity to anticoagulants or any other contraindication to anticoagulant therapy.
Presence of systemic bleeding disorders, coagulopathy, or a platelet count <100 × 10⁹/L.
Trial design
Design model
Parallel
Treatments tested in this trial
Early Initiation of DOAC Therapy
Other interventionParticipants assigned to the intervention group will initiate DOAC therapy 24 hours after endovascular therapy (EVT). For patients receiving antiplatelet therapy before enrollment, antiplatelet agents will be discontinued upon initiation of DOAC therapy.
Antiplatelet Bridging Followed by DOAC Therapy
Other interventionDOAC therapy will be initiated 5 days after randomization. Before DOAC initiation, patients will receive bridging therapy with a single antiplatelet agent, consisting of either aspirin 100 mg once daily or clopidogrel 75 mg once daily. Dual antiplatelet therapy is not permitted. Antiplatelet therapy will be discontinued upon initiation of DOAC therapy.
Treatment groups
474 Participants
are divided into 2 treatment groupsGroup A: Early Initiation of DOAC TherapyExperimental treatment 1 intervention
Group B: Antiplatelet Bridging Followed by DOAC TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional independence (90-day mRS score ≤ 1)
Modified Rankin Scale (mRS). Scores range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate a worse outcome.
Time frame
At 90 days after randomizationSecondary outcomes
1
Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, or all-cause mortality within 90 days
Time frame
At 90 days after randomization2
Recurrent ischemic stroke within 90 days
Time frame
At 90 days after randomization3
Venous thromboembolic events within 90 days
Time frame
At 90 days after randomization4
Systemic embolic events within 90 days
Time frame
At 90 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hao Yonggang
Lead sponsor
The Fourth Affiliated Hospital of Soochow University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: