Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)

NCT ID: NCT03701360

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2021-07-14

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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Aspirin alone group

\- Aspirin: 75\~100mg once per day, initial loading dose of 300\~500mg/d is allowed

No interventions assigned to this group

Aspirin + Clopidogrel resinate group

• Aspirin: 75~100mg once per day, initial loading dose of 300~500mg/d is allowed
• Clopidogrel resinate: 75mg once per day, initial loading dose of 300mg/d is allowed

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Male and/or female subjects who are aged 19 or over.

2. Patients with acute non-cardiac stroke or transient ischemic attack within 72 hours of the onset (in the case of a transient ischemic attack, presence of ischemic/ischemic lesion on DWI or PWI).

3. Patients whose informed consent document within 72 hours of onset was signed and submitted.

4. Patients who were treated with aspirin alone or aspirin plus clopidogrel resinate following stroke.

Exclusion Criteria

1. Patients who need anticoagulants for cardiac ischemic stroke or other reasons.

2. Patients who suffered severe stroke (National Institutes of Health Stroke Scale> 16).

3. Patients who received emergency remission therapies such as tPA and thrombolysis.

4. Patients with neurological deterioration prior to signing an informed written consent document.

5. Patients who have undergone patency procedures (surgery or stent insertion) in the cerebrovascular or carotid arteries following stroke or are expected to do so.

6. Patients who are scheduled to undergo major surgery.

7. Patients who developed stroke during procedure/surgery.

8. Patients with recent history (in the past three months) of cerebral hemorrhage.

9. Patients with active internal bleeding.

10. Patients with severe anemia (Hb <10 g / dL) or bleeding tendency (platelet <100,000 / uL or PT-INR> 1.7).

11. When a patient's life expectancy is less than 6 months due to other systemic disease.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dong-Wha Kang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Wha Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Dong-Wha Kang

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PRECISE

Identifier Type: -

Identifier Source: org_study_id