Actively Recruiting
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Led by Nippon Medical School · Updated on 2026-02-03
500
Participants Needed
27
Research Sites
191 weeks
Total Duration
On this page
Sponsors
N
Nippon Medical School
Lead Sponsor
J
Japan Research Foundation for Clinical Pharmacology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute ischemic stroke within 4.5 hours from symptom onset or last known well time
- Single perforating-artery infarct on brain MRI located in the corona radiata, putamen, internal capsule, thalamus, or pons
- Infarct is solitary, mainly round or oval, with a maximum diameter of 20 mm
- Lesions only in the centrum semiovale are not allowed, but extension from other specified sites into the centrum semiovale is allowed
- No disability in daily life before the stroke (modified Rankin Scale score 0 or 1)
- National Institutes of Health Stroke Scale (NIHSS) score 5 or less
- Written informed consent obtained
You will not qualify if you...
- Antithrombotic therapy considered inappropriate due to active bleeding, low platelet count, or similar conditions
- Any contraindication to intravenous rt-PA treatment
- 50% or more stenosis or occlusion of the artery responsible for the stroke
- Diseases requiring anticoagulation (such as atrial fibrillation or deep vein thrombosis)
- Inability to take medicine orally
- Any other reason judged by the investigators to make participation inappropriate
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Trial Site Locations
Total: 27 locations
1
University of Yamanashi Hospital
Chūō, Japan
Actively Recruiting
2
Fukuoka Red Cross Hospital
Fukuoka, Japan
Actively Recruiting
3
Ota Memorial Hospital
Fukuyama, Japan
Actively Recruiting
4
Kansai Medical University Hospital
Hirakata, Japan
Actively Recruiting
5
Kagoshima City Hospital
Kagoshima, Japan
Actively Recruiting
6
Kagoshima Medical Center
Kagoshima, Japan
Actively Recruiting
7
Shioda Hospital
Katsuura, Japan
Actively Recruiting
8
St. Marianna University School of Medicine Hospital
Kawasaki, Japan
Actively Recruiting
9
The Jikei University West Medical Center
Komae, Japan
Actively Recruiting
10
Kawasaki Medical School Hospital
Kurashiki, Japan
Actively Recruiting
11
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
Actively Recruiting
12
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Actively Recruiting
13
The Jikei University Hospital
Minatoku, Japan
Actively Recruiting
14
Kawasaki Medical School General Medical Center
Okayama, Japan
Actively Recruiting
15
Kohnan Hospital
Sendai, Japan
Actively Recruiting
16
Jichi Medical University Hospital
Shimotsuke, Japan
Actively Recruiting
17
Nippon Medical School Tamanagayama hospital
Tama, Japan
Actively Recruiting
18
Dokkyo Medical University Hospital
Tochigi, Japan
Actively Recruiting
19
Tokushima University Hospital
Tokushima, Japan
Actively Recruiting
20
Juntendo University Hospital
Tokyo, Japan
Actively Recruiting
21
Nippon Medical School hospital
Tokyo, Japan
Actively Recruiting
22
Science Tokyo Hospital
Tokyo, Japan
Actively Recruiting
23
Tokyo Rosai Hospital
Tokyo, Japan
Actively Recruiting
24
Tokyo Saiseikai Central Hospital
Tokyo, Japan
Actively Recruiting
25
Tokyo Women's Medical University Hospital
Tokyo, Japan
Actively Recruiting
26
Yamaguchi University Hospital
Ube, Japan
Actively Recruiting
27
Juntendo University Urayasu Hospital
Urayasu, Japan
Actively Recruiting
Research Team
Y
Yuki Sakamoto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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