StrokeNCT03701360
Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
An observational study of Stroke, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This is a pragmatic, multi-center, non-interventional, non-randomized prospective observational study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,199 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2018to 14 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients: Transient ischemic attack with confirmed acute ischemic stroke by brain imaging
Who may be able to join
- Male and/or female subjects who are aged 19 or over.
- 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).
- Patients whose informed consent document within 72 hours of onset was signed and submitted.
- Patients who were treated with aspirin alone or aspirin plus clopidogrel resinate following stroke.
Who cannot join
- Patients who need anticoagulants for cardiac ischemic stroke or other reasons.
- Patients who suffered severe stroke (National Institutes of Health Stroke Scale> 16).
- Patients who received emergency remission therapies such as tPA and thrombolysis.
- Patients with neurological deterioration prior to signing an informed written consent document.
- Patients who have undergone patency procedures (surgery or stent insertion) in the cerebrovascular or carotid arteries following stroke or are expected to do so.
- Patients who are scheduled to undergo major surgery.
Show all 11Show fewer
- Patients who developed stroke during procedure/surgery.
- Patients with recent history (in the past three months) of cerebral hemorrhage.
- Patients with active internal bleeding.
- Patients with severe anemia (Hb <10 g / dL) or bleeding tendency (platelet <100,000 / uL or PT-INR> 1.7).
- When a patient's life expectancy is less than 6 months due to other systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
This is a pragmatic, multi-center, non-interventional, non-randomized prospective observational study.
Read the 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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin alone group | - Aspirin: 75~100mg once per day, initial loading dose of 300~500mg/d is allowed | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with neurological deterioration under hospital treatment.
Rapid worsening of an existing focal neurological deficit or rapid onset of a new focal neurological deficit (≥ 24 hours) that is clinically judged by the Investigator not to be attributable to non-ischemic etiology.
Measured: up to 3 months after stroke onset
Rate of patients with new ischemic stroke under hospital treatment.
- Rapid onset of a new focal neurological deficit with clinical or imaging evidence of infarction and not attributable to a non-ischemic etiology (not associated with brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease); or,
- Rapid worsening of an existing focal neurological deficit that is judged by the Investigator to be attributable to a new infarction. Criteria for symptoms attributable to new infarction may include symptoms that persist and are judged by the investigator to be attributable to new infarction, imaging evidence of infarction, or no evidence of a non-ischemic etiology.
Measured: up to 3 months after stroke onset
Rate of patients with symptomatic hemorrhagic transformation of an ischemic stroke under hospital treatment.
Imaging evidence (by CT or MR) of extravascular blood within the area of infarction, and symptoms judged to be related to the hemorrhagic transformation.
Scenarios which may be judged as symptomatic:
- If blood is already present on imaging at presentation, symptoms are out of proportion to what would be expected for the size and location of the infarct at presentation;
- Clinical deterioration, defined by an increase of 4 points or more in the score on the NIHSS or leading to death, occurring after the initial ischemic event, and identified as the result of the hemorrhagic transformation; or
- Mass effect secondary to the hemorrhagic transformation causing symptoms.
Measured: up to 3 months after stroke onset
Rate of patients with symptomatic intracranial hemorrhage under hospital treatment.
Evidence of hemorrhage in the brain parenchyma or extraparenchymal spaces demonstrated by head imaging, surgery, or autopsy, which is not in the same territory of an underlying acute or subacute ischemic stroke, and is judged to be associated with any new neurologic symptoms (including headache) or leading to death.
Measured: up to 3 months after stroke onset
Rate of patients with myocardial infarction under hospital treatment.
The diagnosis of MI will be based on an algorithm developed from the Universal Definition of Myocardial Infarction (Circulation 2007 116:2634-2653) that takes into account 5 categories of clinical information from the acute event: rise and/or fall of cardiac biomarkers, ECG abnormalities, clinical setting, imaging evidence, and pathology.
Measured: up to 3 months after stroke onset
Rate of patients with coronary revascularization without myocardial infarction under hospital treatment.
Documented coronary angioplasty, stenting, or bypass surgery for demonstrated or presumed coronary artery disease.
Measured: up to 3 months after stroke onset
Rate of patients with major hemorrhage other than intracranial hemorrhage under hospital treatment.
A hemorrhagic event, judged to be nontraumatic, that results in intraocular bleeding causing loss of vision, the need for a transfusion of two or more units of red cells or the equivalent amount of whole blood, or the need for hospitalization or prolongation of existing hospitalization. This may include bleeding events related to surgical procedures but not those related to accidental trauma. Life-threatening hemorrhagic events will be defined as those that are fatal or require use of intravenous inotropic medication to maintain blood pressure, interventional treatment (including surgical, endoscopic or endovascular interventions), or transfusion of four or more units of red cells or the equivalent amount of whole blood. Non-life-threatening hemorrhagic events will be defined as those classified as major hemorrhagic events but not as life-threatening.
Measured: up to 3 months after stroke onset
Rate of patients with minor hemorrhage other than intracranial hemorrhage under hospital treatment.
All hemorrhagic events leading to interruption of therapy or discontinuation of the study drug but not classifiable as major hemorrhagic events. This may include bleeding events related to surgical procedures but not those related to accidental trauma.
Measured: up to 3 months after stroke onset
Rate of patients with ischemic vascular death under hospital treatment.
Death due to ischemic stroke, myocardial infarction, sudden cardiac death, arrhythmia, pulmonary embolism, bowel or limb infarction, or any death not readily attributable to a non-ischemic cause.
Measured: up to 3 months after stroke onset
Rate of patients with hemorrhagic vascular death under hospital treatment.
Death due to intracranial or systemic hemorrhage.
Measured: up to 3 months after stroke onset
Rate of patients with other serious adverse event under hospital treatment.
Any adverse event, not belonging to the other outcome event categories, that is fatal or life threatening, is permanently or substantially disabling, requires or prolongs hospitalization, results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage.
Measured: up to 3 months after stroke onset
Secondary outcomes (1)
Evaluation by an independent investigator
A direct comparison between the aspirin alone group and the aspirin plus clopidogrel group for the incidence of 11 outcome variables evaluated by an independent investigator at the primary endpoints will be conducted.
Measured: up to 3 months after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start30 Oct 2018
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Wha Kang, Asan Medical Center
- Investigators
- Dong-Wha Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701360
- Sponsor's protocol ID
- PRECISE
- Status last verified
- Feb 2022
- First submitted
- 14 Sep 2018
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
- ClinicalTrials.gov ID
- NCT03701360
- Acronym / sponsor ID
- PRECISE
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin alone group | – | –- Aspirin: 75~100mg once per day, initial loading dose of 300~500mg/d is allowed |
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients: Transient ischemic attack with confirmed acute ischemic stroke by brain imaging
Key inclusion criteria (4 listed)
- Male and/or female subjects who are aged 19 or over.
- 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).
- Patients whose informed consent document within 72 hours of onset was signed and submitted.
- Patients who were treated with aspirin alone or aspirin plus clopidogrel resinate following stroke.
Key exclusion criteria (11 listed)
- Patients who need anticoagulants for cardiac ischemic stroke or other reasons.
- Patients who suffered severe stroke (National Institutes of Health Stroke Scale> 16).
- Patients who received emergency remission therapies such as tPA and thrombolysis.
- Patients with neurological deterioration prior to signing an informed written consent document.
- Patients who have undergone patency procedures (surgery or stent insertion) in the cerebrovascular or carotid arteries following stroke or are expected to do so.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients with neurological deterioration under hospital treatment.
Time frame: up to 3 months after stroke onset
Rapid worsening of an existing focal neurological deficit or rapid onset of a new focal neurological deficit (≥ 24 hours) that is clinically judged by the Investigator not to be attributable to non-ischemic etiology.
Rate of patients with new ischemic stroke under hospital treatment.
Time frame: up to 3 months after stroke onset
* Rapid onset of a new focal neurological deficit with clinical or imaging evidence of infarction and not attributable to a non-ischemic etiology (not associated with brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease); or, * Rapid worsening of an existing focal neurological deficit that is judged by the Investigator to be attributable to a new infarction. Criteria for symptoms attributable to new infarction may include symptoms that persist and are judged by the investigator to be attributable to new infarction, imaging evidence of infarction, or no evidence of a non-ischemic etiology.
Rate of patients with symptomatic hemorrhagic transformation of an ischemic stroke under hospital treatment.
Time frame: up to 3 months after stroke onset
Imaging evidence (by CT or MR) of extravascular blood within the area of infarction, and symptoms judged to be related to the hemorrhagic transformation. Scenarios which may be judged as symptomatic: * If blood is already present on imaging at presentation, symptoms are out of proportion to what would be expected for the size and location of the infarct at presentation; * Clinical deterioration, defined by an increase of 4 points or more in the score on the NIHSS or leading to death, occurring after the initial ischemic event, and identified as the result of the hemorrhagic transformation; or * Mass effect secondary to the hemorrhagic transformation causing symptoms.
Rate of patients with symptomatic intracranial hemorrhage under hospital treatment.
Time frame: up to 3 months after stroke onset
Evidence of hemorrhage in the brain parenchyma or extraparenchymal spaces demonstrated by head imaging, surgery, or autopsy, which is not in the same territory of an underlying acute or subacute ischemic stroke, and is judged to be associated with any new neurologic symptoms (including headache) or leading to death.
Rate of patients with myocardial infarction under hospital treatment.
Time frame: up to 3 months after stroke onset
The diagnosis of MI will be based on an algorithm developed from the Universal Definition of Myocardial Infarction (Circulation 2007 116:2634-2653) that takes into account 5 categories of clinical information from the acute event: rise and/or fall of cardiac biomarkers, ECG abnormalities, clinical setting, imaging evidence, and pathology.
Rate of patients with coronary revascularization without myocardial infarction under hospital treatment.
Time frame: up to 3 months after stroke onset
Documented coronary angioplasty, stenting, or bypass surgery for demonstrated or presumed coronary artery disease.
Rate of patients with major hemorrhage other than intracranial hemorrhage under hospital treatment.
Time frame: up to 3 months after stroke onset
A hemorrhagic event, judged to be nontraumatic, that results in intraocular bleeding causing loss of vision, the need for a transfusion of two or more units of red cells or the equivalent amount of whole blood, or the need for hospitalization or prolongation of existing hospitalization. This may include bleeding events related to surgical procedures but not those related to accidental trauma. Life-threatening hemorrhagic events will be defined as those that are fatal or require use of intravenous inotropic medication to maintain blood pressure, interventional treatment (including surgical, endoscopic or endovascular interventions), or transfusion of four or more units of red cells or the equivalent amount of whole blood. Non-life-threatening hemorrhagic events will be defined as those classified as major hemorrhagic events but not as life-threatening.
Rate of patients with minor hemorrhage other than intracranial hemorrhage under hospital treatment.
Time frame: up to 3 months after stroke onset
All hemorrhagic events leading to interruption of therapy or discontinuation of the study drug but not classifiable as major hemorrhagic events. This may include bleeding events related to surgical procedures but not those related to accidental trauma.
Rate of patients with ischemic vascular death under hospital treatment.
Time frame: up to 3 months after stroke onset
Death due to ischemic stroke, myocardial infarction, sudden cardiac death, arrhythmia, pulmonary embolism, bowel or limb infarction, or any death not readily attributable to a non-ischemic cause.
Rate of patients with hemorrhagic vascular death under hospital treatment.
Time frame: up to 3 months after stroke onset
Death due to intracranial or systemic hemorrhage.
Rate of patients with other serious adverse event under hospital treatment.
Time frame: up to 3 months after stroke onset
Any adverse event, not belonging to the other outcome event categories, that is fatal or life threatening, is permanently or substantially disabling, requires or prolongs hospitalization, results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage.
1 secondary outcome
Evaluation by an independent investigator
Time frame: up to 3 months after stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Wha Kang, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with neurological deterioration under hospital treatment. (time frame: up to 3 months after stroke onset). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.