Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNippon Medical School
About this trial
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 criteria
Qualifiers
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.
No disability in daily life before the stroke (modified Rankin Scale ≤ 1).
National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
Disqualifiers
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) *
Trial design
Treatments tested in this trial
- rt-PA
- DAPT
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nippon Medical School
Lead sponsor
Japan Research Foundation for Clinical Pharmacology
Collaborator
Takeda Science Foundation - Medical Research Grant
Collaborator
Source ClinicalTrials.gov