UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058468 |
|---|---|
| Receipt number | R000066852 |
| Scientific Title | A Prospective Study to Evaluate the Preventive Effect of Dual Antiplatelet Therapy Including P2Y12 Inhibitor Loading on Early Motor Deterioration in Acute Noncardioembolic Ischemic Stroke |
| Date of disclosure of the study information | 2025/07/20 |
| Last modified on | 2025/07/14 21:08:21 |
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Basic information
Public title
Efficacy of Dual Antiplatelet Therapy Including P2Y12 Inhibitor Loading in Preventing Motor Function Deterioration in the Acute Phase of Noncardioembolic Ischemic Stroke
Acronym
Motor Function Preservation with DAPT Including P2Y12 Inhibitor Loading in Acute Noncardioembolic Ischemic Stroke
Scientific Title
A Prospective Study to Evaluate the Preventive Effect of Dual Antiplatelet Therapy Including P2Y12 Inhibitor Loading on Early Motor Deterioration in Acute Noncardioembolic Ischemic Stroke
Scientific Title:Acronym
A Prospective Study on the Prevention of Motor Function Deterioration with DAPT Including P2Y12 Inhibitor Loading in Acute Noncardioembolic Ischemic Stroke
Region
| Japan |
Condition
Condition
Noncardioembolic Ischemic Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Motor paralysis represents a significant functional loss in ischemic stroke, leading to impairment in activities of daily living. The objective of this study is to evaluate the preventive effects on motor function deterioration during the acute phase of non-cardioembolic ischemic stroke and to explore the optimal therapeutic approach.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Worsening of motor NIHSS by 1 point or more at 7 days after treatment initiation
Key secondary outcomes
1. Worsening of motor NIHSS by 1 point or more at 21 days after treatment initiation
2. Modified Rankin Scale at 21 days after treatment initiation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receiving dual antiplatelet therapy including P2Y12 inhibitor loading
Interventions/Control_2
Patients receiving other antiplatelet therapies
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Age: 20 to 85 years
-Able to start antiplatelet therapy within 48 hours of onset
-Diagnosed with non-cardioembolic ischemic stroke
Key exclusion criteria
-Cardioembolic stroke
-Atherothrombotic cerebral infarction
-Stroke of undetermined embolic source
-Patients with bleeding diathesis
-Patients contraindicated for antiplatelet therapy
-Patients for whom motor function assessment is difficult (including higher brain dysfunction and consciousness disturbance)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Jyunshin Hospital
Division name
Department of Neurosurgery
Zip code
675-0122
Address
865-1 Befu, Befu-cho, Kakogawa City, Hyogo Prefecture, Japan
TEL
079-437-3555
njapxblj@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Junshin Hospital Clinical Research Department
Division name
Clinical Neurosurgery Research Department
Zip code
675-0122
Address
865-1 Befu, Befu-cho, Kakogawa City, Hyogo Prefecture, Japan
TEL
079-437-3555
Homepage URL
njapxblj@gmail.com
Sponsor or person
Institute
Junshin Hospital Clinical Neurosurgery Research Department
Institute
Department
Personal name
Funding Source
Organization
Medical Research Fund of Hyogo Medical Association
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Junshin Hospital Clinical Neurosurgery Research Department
Address
865-1 Befu, Befu-cho, Kakogawa City, Hyogo Prefect
Tel
079-437-3555
njapxblj@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
198
Results
Comparison of baseline characteristics and clinical outcomes between patients with and without P2Y12 loading showed no significant differences in age, sex, or comorbidities. However, the loading group had significantly less motor worsening on day 7 (14.9% vs 28.9%, p=0.0243) and better outcomes on day 21 (74.3% vs 57.7%, p=0.0160).
Results date posted
| 2025 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066852
