rt-PA
DrugRecombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.
NCT Number: NCT07111559
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
University of Yamanashi Hospital, Chūō, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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.
Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.
Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.
Time frame: 3 months after stroke
Modified Rankin scale score of 0-1
Time frame: At Day 7
Infarct growth between Day 7 and admission on diffusion-weighted imaging
Time frame: At Day 7
Increment in NIHSS score by 2 points or more from admission
Time frame: At Day 7
NIHSS score on Day 7
Time frame: At 3 months
mRS 0-2 at 3 months from stroke onset
Time frame: At 3 months
mRS distribution (assessed by shift analysis) at 3 months from onset
Time frame: At 3 months
Ischemic stroke recurrence during 3 months from onset
Time frame: Various (such as at 7 days or 3 months)
Cost effectiveness analysis comparing DAPT to rt-PA
Time frame: At 24 hours from the initial treatment
symptomatic intracerebral hemorrhage
Time frame: At 14 days from admission
any intracranial bleeding
Time frame: At 14 days from admission
other hemorrhagic complications
Time frame: At 3 months
all-cause mortality
Time frame: At 3 months
cerebrovascular death
Contact information is provided by the study sponsor or research team.
Nippon Medical School
Other
A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction
Acronym: LACUNAR-tPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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