Menu
Recruiting NCT07111559

Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial

Phase IV Interventional Lacunar Stroke Stroke Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rt-PA, DAPT.
Who it may be relevant to
Registry conditions: Lacunar Stroke, Stroke, Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction

Overview

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.

Interventions

  • Drug rt-PA
    Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.
  • Drug DAPT
    Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.

Primary outcome measures

  • Excellent outcome [Time frame: 3 months after stroke]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

Inclusion 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 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 29 centers
  • University of Yamanashi Hospital — Chūō
  • University of Fukui Hospital — Fukui
  • Fukuoka Red Cross Hospital — Fukuoka
  • Ota Memorial Hospital — Fukuyama
  • Kansai Medical University Hospital — Hirakata
  • Kagoshima City Hospital — Kagoshima
  • Kagoshima Medical Center — Kagoshima
  • Shioda Hospital — Katsuura
  • … and 21 more centers

Identifiers

NCT: NCT07111559 · NMS-M-2024-210

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗