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出境医 / 临床实验 / Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT)

Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT)

Study Description
Brief Summary:
This is a descriptive study designed to evaluate the safety and feasibility of a precision medicine approach to antiplatelet selection for secondary stroke prevention.

Condition or disease Intervention/treatment Phase
Ischemic Stroke TIA Drug: tailored antiplatelet selection Drug: standard of care Phase 2

Detailed Description:
Subjects meeting inclusion/exclusion criteria will be randomly assigned to: (1) the treatment group where antiplatelet medications will be selected using platelet function phenotype and/or key pharmacogene genotypes (2) the control group where participants will receive standard care for antiplatelet therapy (without knowledge of phenotype or genotype).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT). A Randomized, Phase II, Open Label, Trial in High Risk Transient Ischemic Attack (TIA) and Ischemic Stroke Survivors Age 18 Years and Older
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment Group
Intervention group
Drug: tailored antiplatelet selection
antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes

Active Comparator: Control Group
Standard of Care group
Drug: standard of care
antiplatelet selection using standard of care

Outcome Measures
Primary Outcome Measures :
  1. Feasibility - Recruitment and Platelet Reactivity [ Time Frame: 90 days ]
    ability to recruit participants and achieve platelet reactivity target using platelet function assays

  2. Safety - Bleeding Complications [ Time Frame: 90 days ]
    bleeding questionnaire

  3. Safety - Bleeding Complications [ Time Frame: 1 year ]
    bleeding questionnaire


Secondary Outcome Measures :
  1. Patient-centered Outcomes - Satisfaction [ Time Frame: 90 days ]
    consumer assessment of healthcare providers and systems

  2. Patient-centered Outcomes - Satisfaction [ Time Frame: 1 year ]
    consumer assessment of healthcare providers and systems


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Meet criteria for a mild or moderate ischemic stroke or high-risk TIA
  • Ability to randomize within 30 hours of stroke symptom onset/last seen normal time

Exclusion Criteria:

  • Evidence of new or prior non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage, or subdural hemorrhage on initial head CT
  • Evidence of a central nervous system tumor, abscess, intracranial aneurysm or vascular/structural malformation, or any neuro-inflammatory, neuro-infectious, or neurodegenerative disorder on neuroimaging or exam that could confound a participant's functional outcome
  • Isolated or pure sensory symptoms (e.g., numbness), visual changes, or "dizziness"/vertigo without evidence of acute ischemic stroke on baseline head CT or MRI.
  • Qualifying ischemic event is believed to be iatrogenic or procedure related
  • Required to take a specific antiplatelet medication for an indication other than ischemic stroke during the study period that would prevent the investigator from following the study algorithm
  • Etiology of qualifying ischemic event is known to be cardioembolic
  • High likelihood that anticoagulation will be needed during the study period.
  • High likelihood that carotid endarterectomy or carotid stenting will occur during the period of the study.
  • Pre-stroke modified Rankin scale (mRS) score ≥ 3
  • Evidence of frailty
  • Contraindication to aspirin, clopidogrel, Aggrenox®, or ticagrelor
  • Known allergy or hypersensitivity that would prevent the investigator from following the study algorithm
  • Any history of moderate to severe drug-induced adverse events
  • Renal insufficiency or history of kidney transplant
  • Hepatic impairment, international normalized ratio (INR) > 1.5, physical manifestations of liver disease, or history of liver transplant
  • Class II, III, or IV New York Heart Association (NYHA) functional heart failure
  • Any history of bradycardia without pacemaker placement
  • Active obstructive lung disease
  • Any active hematologic disorder
  • Active bleeding diathesis
  • Any systemic hemorrhage or GI bleed in the 3 months prior to the qualifying stroke
  • Active peptic ulcer disease
  • Women who self-report that they are pregnant or breastfeeding
  • Active alcohol or substance abuse or dependence
  • Inability or failure to provide informed consent.
  • Inability of the patient to adhere to study procedures and/or follow-up, in the opinion of the investigative team
  • Inability to swallow oral medications
  • Not willing or able to discontinue prohibited concomitant medications
  • Ongoing participation in another non-observational clinical study
  • Life expectancy < 1 year, in the opinion of the investigative team
Contacts and Locations

Contacts
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Contact: Karen C Albright, PhD, DO 315-464-4689 AlbrighK@upstate.edu
Contact: Michelle Klick, LPN, CCRP 315-464-5729 KlickM@upstate.edu

Locations
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United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13202
Contact: Karen C Albright, PhD, DO    315-464-6489    AlbrighK@upstate.edu   
Contact: Michelle Klick, LPN, CCRP    3154645729    KlickM@upstate.edu   
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
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Principal Investigator: Karen C Albright, PhD, DO State University of New York - Upstate Medical University
Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE June 11, 2018
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Feasibility - Recruitment and Platelet Reactivity [ Time Frame: 90 days ]
    ability to recruit participants and achieve platelet reactivity target using platelet function assays
  • Safety - Bleeding Complications [ Time Frame: 90 days ]
    bleeding questionnaire
  • Safety - Bleeding Complications [ Time Frame: 1 year ]
    bleeding questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Patient-centered Outcomes - Satisfaction [ Time Frame: 90 days ]
    consumer assessment of healthcare providers and systems
  • Patient-centered Outcomes - Satisfaction [ Time Frame: 1 year ]
    consumer assessment of healthcare providers and systems
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Antiplatelet Secondary Stroke PRevenTion
Official Title  ICMJE Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT). A Randomized, Phase II, Open Label, Trial in High Risk Transient Ischemic Attack (TIA) and Ischemic Stroke Survivors Age 18 Years and Older
Brief Summary This is a descriptive study designed to evaluate the safety and feasibility of a precision medicine approach to antiplatelet selection for secondary stroke prevention.
Detailed Description Subjects meeting inclusion/exclusion criteria will be randomly assigned to: (1) the treatment group where antiplatelet medications will be selected using platelet function phenotype and/or key pharmacogene genotypes (2) the control group where participants will receive standard care for antiplatelet therapy (without knowledge of phenotype or genotype).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Stroke
  • TIA
Intervention  ICMJE
  • Drug: tailored antiplatelet selection
    antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes
  • Drug: standard of care
    antiplatelet selection using standard of care
Study Arms  ICMJE
  • Experimental: Treatment Group
    Intervention group
    Intervention: Drug: tailored antiplatelet selection
  • Active Comparator: Control Group
    Standard of Care group
    Intervention: Drug: standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Meet criteria for a mild or moderate ischemic stroke or high-risk TIA
  • Ability to randomize within 30 hours of stroke symptom onset/last seen normal time

Exclusion Criteria:

  • Evidence of new or prior non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage, or subdural hemorrhage on initial head CT
  • Evidence of a central nervous system tumor, abscess, intracranial aneurysm or vascular/structural malformation, or any neuro-inflammatory, neuro-infectious, or neurodegenerative disorder on neuroimaging or exam that could confound a participant's functional outcome
  • Isolated or pure sensory symptoms (e.g., numbness), visual changes, or "dizziness"/vertigo without evidence of acute ischemic stroke on baseline head CT or MRI.
  • Qualifying ischemic event is believed to be iatrogenic or procedure related
  • Required to take a specific antiplatelet medication for an indication other than ischemic stroke during the study period that would prevent the investigator from following the study algorithm
  • Etiology of qualifying ischemic event is known to be cardioembolic
  • High likelihood that anticoagulation will be needed during the study period.
  • High likelihood that carotid endarterectomy or carotid stenting will occur during the period of the study.
  • Pre-stroke modified Rankin scale (mRS) score ≥ 3
  • Evidence of frailty
  • Contraindication to aspirin, clopidogrel, Aggrenox®, or ticagrelor
  • Known allergy or hypersensitivity that would prevent the investigator from following the study algorithm
  • Any history of moderate to severe drug-induced adverse events
  • Renal insufficiency or history of kidney transplant
  • Hepatic impairment, international normalized ratio (INR) > 1.5, physical manifestations of liver disease, or history of liver transplant
  • Class II, III, or IV New York Heart Association (NYHA) functional heart failure
  • Any history of bradycardia without pacemaker placement
  • Active obstructive lung disease
  • Any active hematologic disorder
  • Active bleeding diathesis
  • Any systemic hemorrhage or GI bleed in the 3 months prior to the qualifying stroke
  • Active peptic ulcer disease
  • Women who self-report that they are pregnant or breastfeeding
  • Active alcohol or substance abuse or dependence
  • Inability or failure to provide informed consent.
  • Inability of the patient to adhere to study procedures and/or follow-up, in the opinion of the investigative team
  • Inability to swallow oral medications
  • Not willing or able to discontinue prohibited concomitant medications
  • Ongoing participation in another non-observational clinical study
  • Life expectancy < 1 year, in the opinion of the investigative team
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen C Albright, PhD, DO 315-464-4689 AlbrighK@upstate.edu
Contact: Michelle Klick, LPN, CCRP 315-464-5729 KlickM@upstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979781
Other Study ID Numbers  ICMJE 1158092
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party State University of New York - Upstate Medical University
Study Sponsor  ICMJE State University of New York - Upstate Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen C Albright, PhD, DO State University of New York - Upstate Medical University
PRS Account State University of New York - Upstate Medical University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP