Health TrialsbyHealthPanel

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

ConditionsLacunar StrokeStrokeIschemic Stroke
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • rt-PA

    Drug

    Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.

  • DAPT

    Drug

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: rt-PAActive comparator 1 intervention
Group B: DAPTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Excellent outcome

Modified Rankin scale score of 0-1

Time frame
3 months after stroke

Secondary outcomes

1

Infarct growth between Day 7 and admission

Infarct growth between Day 7 and admission on diffusion-weighted imaging

Time frame
At Day 7
2

Early neurological deterioration

Increment in NIHSS score by 2 points or more from admission

Time frame
At Day 7
3

NIHSS score on Day 7

NIHSS score on Day 7

Time frame
At Day 7
4

Good outcome

mRS 0-2 at 3 months from stroke onset

Time frame
At 3 months

Other outcomes

1

Safety - symptomatic intracerebral hemorrhage

symptomatic intracerebral hemorrhage

Time frame
At 24 hours from the initial treatment
2

Safety - any intracranial bleeding

any intracranial bleeding

Time frame
At 14 days from admission
3

Safety - other hemorrhagic complications

other hemorrhagic complications

Time frame
At 14 days from admission
4

Safety - all-cause mortality

all-cause mortality

Time frame
At 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nippon Medical School

Lead sponsor

Japan Research Foundation for Clinical Pharmacology

Collaborator

Takeda Science Foundation - Medical Research Grant

Collaborator

Source ClinicalTrials.gov
Apply now