Clinical trial NCT03701360: Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
Official title: Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 1199
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients:

Transient ischemic attack with confirmed acute ischemic stroke by brain imaging

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.

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.

Primary outcomes:
measure: Rate of patients with neurological deterioration under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with new ischemic stroke under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with symptomatic hemorrhagic transformation of an ischemic stroke under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with symptomatic intracranial hemorrhage under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with myocardial infarction under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with coronary revascularization without myocardial infarction under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with major hemorrhage other than intracranial hemorrhage under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with minor hemorrhage other than intracranial hemorrhage under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with ischemic vascular death under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with hemorrhagic vascular death under hospital treatment.
timeFrame: up to 3 months after stroke onset
measure: Rate of patients with other serious adverse event under hospital treatment.
timeFrame: up to 3 months after stroke onset
Secondary outcomes:
measure: Evaluation by an independent investigator
timeFrame: up to 3 months after stroke onset
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dong-Wha Kang
Study officials:
affiliation: Asan Medical Center
name: Dong-Wha Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: