Lacunar Stroke, Stroke, Ischemic Stroke
Conditions
Keywords
rt-PA, tissue-plasminogen activator, DAPT, dual antiplatelet therapy
Brief 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.
Interventions
Sponsors
Nippon Medical School
Japan Research Foundation for Clinical Pharmacology
Takeda Science Foundation - Medical Research Grant
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions. * Any contraindication to intravenous rt-PA, without blood pressures. * ≥ 50 % stenosis or occlusion of the artery responsible for the stroke \* (see note below). * Diseases that require anticoagulation (e.g., atrial fibrillation, deep-vein thrombosis) \* * Inability to take medicine orally. * Any other reason judged by the principal investigator or co-investigators to make participation inappropriate. Note: This study targets hyper-acute stroke within 4.5 hours. To avoid treatment delay, items marked with \* must be judged using the similar examinations that each site normally performs before rt-PA administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent outcome | 3 months after stroke | Modified Rankin scale score of 0-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infarct growth between Day 7 and admission | At Day 7 | Infarct growth between Day 7 and admission on diffusion-weighted imaging |
| Early neurological deterioration | At Day 7 | Increment in NIHSS score by 2 points or more from admission |
| NIHSS score on Day 7 | At Day 7 | NIHSS score on Day 7 |
| Good outcome | At 3 months | mRS 0-2 at 3 months from stroke onset |
| mRS distribution at 3 months | At 3 months | mRS distribution (assessed by shift analysis) at 3 months from onset |
| Ischemic stroke recurrence | At 3 months | Ischemic stroke recurrence during 3 months from onset |
| Cost effectiveness of DAPT | Various (such as at 7 days or 3 months) | Cost effectiveness analysis comparing DAPT to rt-PA |
Countries
Japan
Contacts
CONTACTYuki Sakamoto
PRINCIPAL_INVESTIGATORYuki Sakamoto
Nippon Medical School
Outcome results
None listed