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New treatment option for Lacunar Stroke
Official title Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
ClinicalTrials.gov ID: NCT07111559
What this study is testing
What is rt-PA?
rt-PA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lacunar stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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"...
- A single perforating-artery infarct on brain MRI: located in the corona radiata, putamen, internal capsule, thalamus, or pons; solitary, mainly round...
- No disability in daily life before the stroke (modified Rankin Scale ≤ 1).
- National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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 \...
The study team makes the final eligibility decision.
Where it's taking place
- Chūō, Japan
- Fukui, Japan
- Fukuoka, Japan
- Fukuyama, Japan
- Hirakata, Japan
- Kagoshima, Japan
- Katsuura, Japan
- Kawasaki, Japan
- Komae, Japan
- Kurashiki, Japan
- Kyoto, Japan
- Minatoku, Japan
- Okayama, Japan
- Sendai, Japan
- Shimotsuke, Japan
- Tama, Japan
- Tochigi, Japan
- Tokushima, Japan
- Tokyo, Japan
- Ube, Japan
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chūō, Japan; Fukui, Japan; Fukuoka, Japan; Fukuyama, Japan; Hirakata, Japan; Kagoshima, Japan and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.