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

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ClinicalTrials.gov Identifier: NCT03701360
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-Wha Kang, Asan Medical Center

Brief Summary:
This is a pragmatic, multi-center, non-interventional, non-randomized prospective observational study.

Condition or disease
Stroke

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 Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Anti-platelet Precision Medicine to Prevent Stroke Early Progression and Recurrence (PRECISE)
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Secondary Outcome Measures :
  1. Evaluation by an independent investigator [ Time Frame: up to 3 months after stroke onset ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Acute ischemic stroke patients:

Transient ischemic attack with confirmed acute ischemic stroke by brain imaging

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701360


Contacts
Contact: Dong-Wha Kang, MD, PhD 82-2-3010-3440 dwkang@amc.seoul.kr

Locations
Korea, Republic of
Dong-Wha Kang Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Dong-Wha Kang, MD, PhD    82-3010-3968    dwkang@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Dong-Wha Kang, MD, PhD Asan Medical Center
  Study Documents (Full-Text)

Documents provided by Dong-Wha Kang, Asan Medical Center:
Study Protocol  [PDF] July 23, 2018


Responsible Party: Dong-Wha Kang, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03701360     History of Changes
Other Study ID Numbers: PRECISE
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Recurrence
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics