Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT)

December 14, 2023 updated by: State University of New York - Upstate Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment and Platelet Reactivity
Time Frame: 90 days
ability to recruit participants and achieve platelet reactivity target using platelet function assays
90 days
Safety - Bleeding Complications
Time Frame: 90 days
bleeding questionnaire
90 days
Safety - Bleeding Complications
Time Frame: 1 year
bleeding questionnaire
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-centered Outcomes - Satisfaction
Time Frame: 90 days
consumer assessment of healthcare providers and systems
90 days
Patient-centered Outcomes - Satisfaction
Time Frame: 1 year
consumer assessment of healthcare providers and systems
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York - Upstate Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen C Albright, PhD, DO, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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