NCT07111559

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
36mo left

Started Aug 2025

Longer than P75 for phase_4

Geographic Reach
1 country

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Aug 2025Mar 2029

First Submitted

Initial submission to the registry

August 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

August 1, 2025

Last Update Submit

February 1, 2026

Conditions

StrokeIschemic StrokeLacunar Stroke

Keywords

rt-PAtissue-plasminogen activatorDAPTdual antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • Excellent outcome

    Modified Rankin scale score of 0-1

    3 months after stroke

Secondary Outcomes (7)

  • Infarct growth between Day 7 and admission

    At Day 7

  • Early neurological deterioration

    At Day 7

  • NIHSS score on Day 7

    At Day 7

  • Good outcome

    At 3 months

  • mRS distribution at 3 months

    At 3 months

  • +2 more secondary outcomes

Other Outcomes (5)

  • Safety - symptomatic intracerebral hemorrhage

    At 24 hours from the initial treatment

  • Safety - any intracranial bleeding

    At 14 days from admission

  • Safety - other hemorrhagic complications

    At 14 days from admission

  • +2 more other outcomes

Study Arms (2)

rt-PA

ACTIVE COMPARATOR
Drug: rt-PA

DAPT

EXPERIMENTAL
Drug: DAPT

Interventions

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.

rt-PA
DAPTDRUG

Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.

DAPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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" 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.

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

University of Yamanashi Hospital

Chūō, Japan

RECRUITING

Fukuoka Red Cross Hospital

Fukuoka, Japan

RECRUITING

Ota Memorial Hospital

Fukuyama, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata, Japan

RECRUITING

Kagoshima City Hospital

Kagoshima, Japan

RECRUITING

Kagoshima Medical Center

Kagoshima, Japan

RECRUITING

Shioda Hospital

Katsuura, Japan

RECRUITING

St. Marianna University School of Medicine Hospital

Kawasaki, Japan

RECRUITING

The Jikei University West Medical Center

Komae, Japan

RECRUITING

Kawasaki Medical School Hospital

Kurashiki, Japan

RECRUITING

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

RECRUITING

The Jikei University Hospital

Minatoku, Japan

RECRUITING

Kawasaki Medical School General Medical Center

Okayama, Japan

RECRUITING

Kohnan Hospital

Sendai, Japan

RECRUITING

Jichi Medical University Hospital

Shimotsuke, Japan

RECRUITING

Nippon Medical School Tamanagayama hospital

Tama, Japan

RECRUITING

Dokkyo Medical University Hospital

Tochigi, Japan

RECRUITING

Tokushima University Hospital

Tokushima, Japan

RECRUITING

Juntendo University Hospital

Tokyo, Japan

RECRUITING

Nippon Medical School hospital

Tokyo, Japan

RECRUITING

Science Tokyo Hospital

Tokyo, Japan

RECRUITING

Tokyo Rosai Hospital

Tokyo, Japan

RECRUITING

Tokyo Saiseikai Central Hospital

Tokyo, Japan

RECRUITING

Tokyo Women's Medical University Hospital

Tokyo, Japan

RECRUITING

Yamaguchi University Hospital

Ube, Japan

RECRUITING

Juntendo University Urayasu Hospital

Urayasu, Japan

RECRUITING

MeSH Terms

Conditions

Stroke, LacunarStrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesThrombotic StrokeVascular DiseasesCardiovascular DiseasesBrain InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yuki Sakamoto

    Nippon Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuki Sakamoto

CONTACT

+81-3-3822-2131yuki-sakamoto@nms.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

On reasonable request.

Locations

JP(27)