Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-22 @ 6:46 AM
Study NCT ID:
NCT03701360
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2018-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pragmatic, multi-center, non-interventional, non-randomized prospective observational study.
Detailed Description:
This is a prospective study of patients with acute stroke or transient ischemic attack within 72 hours of symptom onset. It is to mainly observe the patients' prognosis following the prescription of clopidogrel resinate and aspirin, collect relevant data and create big data for stroke. Based on this data, an AI, using various advanced statistical methodologies and deep learning techniques will be developed, and offer information regarding stroke prognosis by extracting markers that are characteristic of the relationship between stroke and the study drug.
These analyses and results will include information on which drug regimen will better prevent the progression or recurrence of stroke by considering individual patient conditions. This is a pragmatic trial based on the prescription and treatment processes of routine clinical practice. Thus, there is no major restriction and with only the minimum exclusion criteria in place, it does not hinder usual clinical practices. Therefore, selecting and changing a patient's antiplatelet agents should be a rational medical judgment made by the patient's attending physician. The study will proceed without any major change in the sequence of routine clinical examinations, prescriptions, treatments, observations, etc. Provided, the process of storing and analyzing relevant information will be added to each study procedure in accordance with study methodologies and conditions no other special efforts or limitations will be required.
The data will be collected prospectively, and the AI will generate brain imaging data and prognostic indicators for 3-months after stroke has occurred. The performance of the AI will be verified with independent test sets.
These analyses and results will include information on which drug regimen will better prevent the progression or recurrence of stroke by considering individual patient conditions. This is a pragmatic trial based on the prescription and treatment processes of routine clinical practice. Thus, there is no major restriction and with only the minimum exclusion criteria in place, it does not hinder usual clinical practices. Therefore, selecting and changing a patient's antiplatelet agents should be a rational medical judgment made by the patient's attending physician. The study will proceed without any major change in the sequence of routine clinical examinations, prescriptions, treatments, observations, etc. Provided, the process of storing and analyzing relevant information will be added to each study procedure in accordance with study methodologies and conditions no other special efforts or limitations will be required.
The data will be collected prospectively, and the AI will generate brain imaging data and prognostic indicators for 3-months after stroke has occurred. The performance of the AI will be verified with independent test sets.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: