BAD-DAPT Study

JRCT ID: jRCT1041220038

Registered date:24/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ischemic stroke
• Date of first enrollment: 14/09/2022
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Test drug group
One prasugrel tablet 3.75 mg is taken once a day with a glass of water.

Control drug group
Take four 75 mg clopidogrel tablets with a glass of water for the first time. After the next day, the patient takes one tablet once a day.

Other treatments are the same in the two groups.

Outcome(s)

Primary Outcome

Percentage of patients who develop worsening neurological symptoms within 7 days of starting treatment
Definition of worsening: paralysis of upper or lower limbs or dysarthria worsened by at least 1 point on the NIHSS.

Secondary Outcome

Number of days until worsening of neurological symptoms
MRI diffusion-weighted image lesion area on day 7 and ratio to area on admission
Platelet aggregation capacity at day 7

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with lesions larger than 15 mm in diameter in the region of the lenticulostriate artery on diffusion-weighted MRI, and in the region of the pontine paramedian artery , where the infarcted lesion abuts the ventral side of the pons base, or whose infarction in the same region does not meet the above criteria but whose symptoms progress between onset and hospital visit.
(2) Patients who are hospitalized within 48 hours of onset
(3) Patients with hypertension, diabetes, dyslipidemia, chronic kidney disease, or history of cerebral infarction
(4) Patients aged 20 years or older on the date of enrollment
(5) Patients who have obtained written consent to participate in this study from the patient or the patient's surrogate.

Exclude criteria

(1) Patients taking antiplatelet drugs other than aspirin
(2) Patients with more than 50% stenotic lesion in the main artery branching the responsible vessel
(3) Patients with atrial fibrillation
(4) Patients who are bleeding or at high risk of bleeding
(hemophilia, intracranial hemorrhage, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)
(5) Patients taking oral anticoagulants
(6) Patients who used thrombolytic therapy (alteplase) for hyperacute stroke
(7) Patients with severe paralysis of the upper or lower limbs at the time of admission (corresponding NIHSS score of 4 = equivalent to MMT0)
(8) Patients with hypersensitivity to clopidogrel or prasugrel
(9) Patients who are unable to undergo MRI imaging due to non-MRI compatible pacemakers, other metal implants, claustrophobia, etc.
(10) Other patients deemed inappropriate as research subjects by the principal/assistant investigator

Related Information

• Primary Sponsor: Inoue Hiroyasu