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.
This is a multicenter, prospective, open-label, randomized controlled trial evaluating the safety and efficacy of different initiation timings of direct oral anticoagulants (DOACs) therapy in patients with acute ischemic stroke related to atrial fibrillation who develop hemorrhagic transformation after emergency endovascular therapy (EVT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Early initiation of direct oral anticoagulants will be started within 4 weeks after symptom onset.
Delayed initiation of direct oral anticoagulants will be started between 4-8 weeks after symptom onset.
Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death
Time frame: 90 days
Incidence of recurrent ischemic stroke
Time frame: 90 days
Incidence of venous thromboembolism
Time frame: 90 days
Incidence of systemic embolism
Time frame: 90 days
Incidence of myocardial infarction
Time frame: 90 days
Proportion of patients achieving mRS 0-2 at 90 Days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Proportion of patients achieving mRS 0-3 at 90 Days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Length of hospital stay for stroke-related care
Time frame: 90 days
Quality of life at 90 days assessed by EuroQol 5 Dimensions 5 level questionnaire [EQ-5D-5L]
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Time frame: 90 days
Incidence of vascular death
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Ma'anshan People's Hospital
Ma’anshan, Anhui, China
RECRUITINGXuanwu Hospital
Beijing, Beijing Municipality, China
RECRUITINGAviation General Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Shijingshan Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
RECRUITINGHeyuan People's Hospital
Heyuan, Guangdong, China
RECRUITINGQinzhou First People's Hospital
Qinzhou, Guangxi, China
RECRUITINGBaoding Sixth Hospital
Baoding, Hebei, China
RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGThe Hongda Hospital of Jiamusi University
Jiamusi, Heilongjiang, China
RECRUITING...and 27 more locations
Time frame: 90 days
All-cause mortality
Time frame: 90 days
Incidence of symptomatic intracranial hemorrhage (sICH)
Time frame: 90 days
Incidence of major extracranial bleeding
Time frame: 90 days