A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years.
• Acute ischemic stroke within 4.5 hours from onset. If onset time is unknown because of impaired consciousness or aphasia, use the last known well time.
• A single perforating-artery infarct on brain MRI:
⁃ located in the corona radiata, putamen, internal capsule, thalamus, or pons; solitary, mainly round or oval, with a maximum diameter ≤ 20 mm; lesions only in the centrum semiovale are not allowed, but extension from the above sites into the centrum semiovale is allowed.
• No disability in daily life before the stroke (modified Rankin Scale ≤ 1).
• National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
• Written informed consent obtained.
Locations
Other Locations
Japan
University of Yamanashi Hospital
RECRUITING
Chūō
Fukuoka Red Cross Hospital
RECRUITING
Fukuoka
Ota Memorial Hospital
RECRUITING
Fukuyama
Kansai Medical University Hospital
RECRUITING
Hirakata
Kagoshima City Hospital
RECRUITING
Kagoshima
Kagoshima Medical Center
RECRUITING
Kagoshima
Shioda Hospital
RECRUITING
Katsuura
St. Marianna University School of Medicine Hospital
RECRUITING
Kawasaki
The Jikei University West Medical Center
RECRUITING
Komae
Kawasaki Medical School Hospital
RECRUITING
Kurashiki
Japanese Red Cross Kyoto Daini Hospital
RECRUITING
Kyoto
University Hospital Kyoto Prefectural University of Medicine