Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT)

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

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

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; TIA
• Intervention / Treatment: Drug: tailored antiplatelet selection; Drug: standard of care

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: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karen C Albright, PhD, DO; Phone Number: 315-464-4689; Email: AlbrighK@upstate.edu
• Study Contact Backup: Name: Michelle Klick, LPN, CCRP; Phone Number: 315-464-5729; Email: KlickM@upstate.edu

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13202
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Recruitment and Platelet Reactivity	ability to recruit participants and achieve platelet reactivity target using platelet function assays	90 days
Safety - Bleeding Complications	bleeding questionnaire	90 days
Safety - Bleeding Complications	bleeding questionnaire	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-centered Outcomes - Satisfaction	consumer assessment of healthcare providers and systems	90 days
Patient-centered Outcomes - Satisfaction	consumer assessment of healthcare providers and systems	1 year

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Karen C Albright, PhD, DO, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: 1158092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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