Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis. Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear. The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,184
Patients in the interventional group will chew 300mg of aspirin enteric-coated tablets as soon as possible after randomization. If swallowing difficulties arise, the tablets can be crushed and administered via a nasogastric tube.
Patients in the control group will chew 300mg of placebos as soon as possible after randomization. If swallowing difficulties arise, the placebo can be crushed and administered via a nasogastric tube.
Patients in both groups will receive the best medical management according to the guidelines.
The Third The People's Hospital Of Bengbu
Bengbu, Anhui, China
RECRUITINGSuzhou municipal hospital
Suzhou, Anhui, China
RECRUITINGXuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGAerospace central hospital
Haidian, Beijing Municipality, China
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 90-days follow up.
Time frame: Ninety days after stroke.
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 30-days follow up.
Time frame: Thirty days after stroke.
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. Functional independence is defined as mRS of 0-2.
Time frame: Ninety days after stroke.
The shift analysis in the 90-day modified Rankin scale (mRS) score.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome.
Time frame: Ninety days after stroke.
The proportion of patients achieving neurological improvement.
Neurological improvement is defined as a decrease of ≥2 points in the NIHSS score at 48 hours of randomization compared to baseline assessment.
Time frame: Within 48 hours after stroke.
The proportion of patients experiencing early neurological deterioration.
Early neurological deterioration is defined as an increase of ≥4 points in the NIHSS score within 24 hours of randomization compared with the minimum NIHSS score before deterioration.
Time frame: Within 24 hours after stroke.
The changes in the NIHSS score at 24 hours, 48 hours, and 7 days of enrollment as compared with the baseline.
The NIHSS ranges from 0 to 42 points, with higher scores indicating worse neurological deficits.
Time frame: Within 7 days after stroke.
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Beijing Pinggu District Hospital
Pinggu, Beijing Municipality, China
RECRUITINGBeijing Luhe Hospital affiliated to Capital Medical University
Tongzhou, Beijing Municipality, China
RECRUITINGFujian university affiliated provincial hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
RECRUITINGXiamen Xinglin hospital
Xiamen, Fujian, China
NOT_YET_RECRUITINGZhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, China
RECRUITING...and 61 more locations