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

Nippon Medical School

Status and phase

Enrolling

Phase 4

Conditions

Ischemic Stroke

Stroke

Lacunar Stroke

Treatments

Drug: DAPT

Drug: rt-PA

Study type

Interventional

Funder types

Other

Identifiers

NCT07111559

NMS-M-2024-210

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.