Lacunar StrokePhase 4LACUNAR-tPANCT07111559
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
A Phase 4 study testing rt-PA and DAPT in people with Lacunar Stroke and Stroke, run by Nippon Medical School at 29 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lacunar Stroke, Stroke, Ischemic Stroke
- What is being tested?
- rt-PA and DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 29 sitesJapan
- Study dates
- 1 Aug 2025to 31 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
Japan29 sites, 29 recruiting
- Recruiting
University of Yamanashi Hospital
Chūō
Yuji Ueno, +81-570-09-3111, uenoy@yamanashi.ac.jp
- Recruiting
University of Fukui Hospital
Fukui
Yasuhiro Nishiyama, +81-776-61-3111, fukunomo@u-fukui.ac
- Recruiting
Fukuoka Red Cross Hospital
Fukuoka
Takuya Okata, +81-570-03-1211, rimata2585@gmail.com
- Recruiting
Ota Memorial Hospital
Fukuyama
Yuka Terasawa, +81-84-931-8650, bbytera@gmail.com
- Recruiting
Kansai Medical University Hospital
Hirakata
+81-570-050-881, yakushiji.yus@kmu.ac.jp
- Recruiting
Kagoshima City Hospital
Kagoshima
Fumio Miyshita, +81-99-230-7000, fu-miya@xc4.so-net.ne.jp
- Recruiting
Kagoshima Medical Center
Kagoshima
Hideki Matsuoka, +81-99-223-1151, hmatsuok0124@yahoo.co.jp
- Recruiting
Shioda Hospital
Katsuura
Koichi Nomura, +81-470-73-1221, k.nomura@nms.ac.jp
- Recruiting
St. Marianna University School of Medicine Hospital
Kawasaki
Hisanao Akiyama, +81-44-977-8111, h2akiyama@marianna-u.ac.jp
- Recruiting
The Jikei University West Medical Center
Komae
Renpei Sengoku, +81-3-3480-1151, renpeis@gmail.com
- Recruiting
Kawasaki Medical School Hospital
Kurashiki
Yoshiki Yagita, +81-86-462-1111, yyagita@med.kawasaki-m.ac.jp
- Recruiting
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Yoshinari Nagakane, +81-75-231-5171, ynagakane@gmail.com
- Recruiting
University Hospital Kyoto Prefectural University of Medicine
Kyoto
Tomoyuki Ohara, +81-75-251-5111, ohatomo@koto.kpu-m.ac.jp
- Recruiting
The Jikei University Hospital
Minatoku
Yasuyuki Iguchi, +81-570-03-2222, yigu@atagobrain.com
- Recruiting
Kawasaki Medical School General Medical Center
Okayama
Takeshi Inoue, +81-86-225-2111, inouet@med.kawasaki-m.ac.jp
- Recruiting
National Cerebral and Cardiovascular Center
Osaka
Kazunori Toyoda, +81-6-6170-1070, toyoda@ncvc.go.jp
- Recruiting
Kohnan Hospital
Sendai
Yukako Yazawa, +81-22-248-2131, yukatin22@gmail.com
- Recruiting
Jichi Medical University Hospital
Shimotsuke
Shigeru Fujimoto, +81-285-44-2111, fujimotos1965@yahoo.co.jp
- Recruiting
Nippon Medical School Tamanagayama hospital
Tama
Tomonari Saito, +81-42-371-2111, s00-36@nms.ac.jp
- Recruiting
Dokkyo Medical University Hospital
Tochigi
Hidehiro Takekawa, +81-282-86-1111, take@dokkyomed.ac.jp
- Recruiting
Tokushima University Hospital
Tokushima
Nobuaki Yamamoto, +81-88-631-3111, nobyamamoto521129@yahoo.co.jp
- Recruiting
Juntendo University Hospital
Tokyo
Nobukazu Miyamoto, +81-3-3813-3111, nobu-m@juntendo.ac.jp
- Recruiting
Nippon Medical School hospital
Tokyo
Yuki Sakamoto, +81-3-3822-2131 ext. 24508, yuki-sakamoto@nms.ac.jp
- Recruiting
Science Tokyo Hospital
Tokyo
Kyohei Fujita, +81-3-3813-6111, fujnuro@tmd.ac.jp
- Recruiting
Tokyo Rosai Hospital
Tokyo
Masahiro Mishina, +81-3-3742-7301, mishina@nms.ac.jp
- Recruiting
Tokyo Saiseikai Central Hospital
Tokyo
Koichi Oki, +81-3-3451-8211, koki.z8@keio.jp
- Recruiting
Tokyo Women's Medical University Hospital
Tokyo
Takao Hoshino, +81-3-3353-8111, hoshino.takao@twmu.ac.jp
- Recruiting
Yamaguchi University Hospital
Ube
Hideyuki Ishihara, +81-836-22-2111, hishi@yamaguchi-u.ac.jp
- Recruiting
Juntendo University Urayasu Hospital
Urayasu
Takao Urabe, +81-47-353-3111, t_urabe@juntendo.ac.jp
About this study
Official title: A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction
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?
Read more
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
- Lacunar Stroke, Stroke, Ischemic Stroke
- Being tested
- rt-PA, DAPT
- Keywords
- rt-PA, tissue-plasminogen activator, DAPT, dual antiplatelet therapy, minor stroke, lacunar stroke
- Medical subject headings
- Stroke, Lacunar, Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rt-PADrug
Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.
DAPTDrug
Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.
| Study group | Role | What they receive |
|---|---|---|
| rt-PA | Active comparator | Not described Receives: Drug: rt-PA |
| DAPT | Experimental | Not described Receives: Drug: DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent outcome
Modified Rankin scale score of 0-1
Measured: 3 months after stroke
Secondary outcomes (7)
Infarct growth between Day 7 and admission
Infarct growth between Day 7 and admission on diffusion-weighted imaging
Measured: At Day 7
Early neurological deterioration
Increment in NIHSS score by 2 points or more from admission
Measured: At Day 7
NIHSS score on Day 7
NIHSS score on Day 7
Measured: At Day 7
Good outcome
mRS 0-2 at 3 months from stroke onset
Measured: At 3 months
mRS distribution at 3 months
mRS distribution (assessed by shift analysis) at 3 months from onset
Measured: At 3 months
Ischemic stroke recurrence
Ischemic stroke recurrence during 3 months from onset
Measured: At 3 months
Cost effectiveness of DAPT
Cost effectiveness analysis comparing DAPT to rt-PA
Measured: Various (such as at 7 days or 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacunar StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nippon Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Research Foundation for Clinical Pharmacology, Takeda Science Foundation - Medical Research Grant
- Responsible party
- Principal investigator, Yuki Sakamoto, Nippon Medical School
- Investigators
- Yuki Sakamoto, Principal investigator, Nippon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111559
- Sponsor's protocol ID
- NMS-M-2024-210
- Acronym
- LACUNAR-tPA
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction
- ClinicalTrials.gov ID
- NCT07111559
- Acronym / sponsor ID
- LACUNAR-tPA / NMS-M-2024-210
- Conditions
- Lacunar Stroke, Stroke, Ischemic Stroke
- Keywords
- rt-PA, tissue-plasminogen activator, DAPT, dual antiplatelet therapy, minor stroke, lacunar stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nippon Medical SchoolUniversity, hospital or other
- Collaborators
- Japan Research Foundation for Clinical Pharmacology, Takeda Science Foundation - Medical Research Grant
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rt-PA | Active comparator | Drug: rt-PA |
| DAPT | Experimental | Drug: DAPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rt-PARecombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan. | Drug | rt-PA |
| DAPTDual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg. | Drug | DAPT |
Primary outcome
Excellent outcome
Time frame: 3 months after stroke
Modified Rankin scale score of 0-1
7 secondary outcomes
Infarct growth between Day 7 and admission
Time frame: At Day 7
Early neurological deterioration
Time frame: At Day 7
NIHSS score on Day 7
Time frame: At Day 7
Good outcome
Time frame: At 3 months
mRS distribution at 3 months
Time frame: At 3 months
Ischemic stroke recurrence
Time frame: At 3 months
Cost effectiveness of DAPT
Time frame: Various (such as at 7 days or 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. On reasonable request.
Related trials for Lacunar Stroke
Active, not recruiting
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Neurologic Disorder, Paralysis
RecruitingObservational study
Cerebral Small Vessel Disease Progression Dependent on Stroke Type
Cerebral Small Vessel Disease, Stroke
RecruitingObservational study
Retinal Vessel Leakage in Cerebral Small Vessel Disease
Cerebral Small Vessel Diseases, Lacunar Stroke
Recruiting
A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts (SALACUNAR)
Lacunar Stroke
Recruiting
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
Lacunar Stroke, Small Vessel Cerebrovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuki Sakamoto principal investigator
Nippon Medical School
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rt-PA and DAPT in people with Lacunar Stroke and Stroke, run by Nippon Medical School at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuki Sakamoto (+81-3-3822-2131 ext. 24508, yuki-sakamoto@nms.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent outcome (time frame: 3 months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.