The goal of this clinical trial is to learn if a combination of antiplatelet drugs works better than intravenous tissue plasminogen activator to treat small ischemic stroke (lacunar stroke). The main questions it aims to answer are: Is a combination of antiplatelet drugs non-inferior to the current standard tissue plasminogen activator treatment? Does a combination of antiplatelet drugs reduce the bleeding complications than tissue plasminogen activator? Researchers will compare a combination of antiplatelet drugs to tissue plasminogen activator to see if a combination of antiplatelet drugs works to treat small ischemic stroke (lacunar stroke). Participants will: Take a combination of antiplatelet drugs or be given intravenous tissue plasminogen activator Check the neurological status 3 months after stroke, in-person, by phone, or by mail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
University of Yamanashi Hospital
Chūō, Japan
RECRUITINGFukuoka Red Cross Hospital
Fukuoka, Japan
RECRUITINGOta Memorial Hospital
Fukuyama, Japan
RECRUITINGKansai Medical University Hospital
Hirakata, Japan
RECRUITINGKagoshima City Hospital
Kagoshima, Japan
RECRUITINGKagoshima Medical Center
Kagoshima, Japan
RECRUITINGShioda Hospital
Katsuura, Japan
RECRUITINGSt. Marianna University School of Medicine Hospital
Kawasaki, Japan
RECRUITINGThe Jikei University West Medical Center
Komae, Japan
RECRUITINGKawasaki Medical School Hospital
Kurashiki, Japan
RECRUITING...and 17 more locations
Excellent outcome
Modified Rankin scale score of 0-1
Time frame: 3 months after stroke
Infarct growth between Day 7 and admission
Infarct growth between Day 7 and admission on diffusion-weighted imaging
Time frame: At Day 7
Early neurological deterioration
Increment in NIHSS score by 2 points or more from admission
Time frame: At Day 7
NIHSS score on Day 7
NIHSS score on Day 7
Time frame: At Day 7
Good outcome
mRS 0-2 at 3 months from stroke onset
Time frame: At 3 months
mRS distribution at 3 months
mRS distribution (assessed by shift analysis) at 3 months from onset
Time frame: At 3 months
Ischemic stroke recurrence
Ischemic stroke recurrence during 3 months from onset
Time frame: At 3 months
Cost effectiveness of DAPT
Cost effectiveness analysis comparing DAPT to rt-PA
Time frame: Various (such as at 7 days or 3 months)
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