PROPELLER study

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: JPRN-jRCTs051230107
• Lead Sponsor: Yamada Shuichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1)Patients with subcortical hemorrhage available for registration within 1 week
2)Patients'age at onset between 50 and 90 years
3)Patients capable of oral intake,including tube feeding
4)Patients who have been fully informed of the details of this clinical research and who have given their written consent,either by the research subject or by a surrogate

Exclusion Criteria

1) Patients with a history of epilepsy
2) Patients taking antiepileptic drugs
3) Patients whose cerebral hemorrhage is known to be caused by a vascular malformation such as arteriovenous malformation or moyamoya disease, or is traumatic in nature
4) Patients with severe renal or hepatic impairment
5) Patients with pregnant or breast feeding
6) Patients with allergy to the target drug
7) Patients who are judged to be inappropriate as research subjects by the principal investigator (subinvestigator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of epilepsy incidence in the first 3 years after initiation of protocol treatment.

Secondary Outcome Measures

Name	Time	Method
1) All mortality during the first 3 years after initiation of protocol treatment.<br>2) Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) in the 3 years after initiation of protocol treatment, regardless of whether it was new or recurrent. New or recurrent stroke is defined here as symptomatic and treated in some way.