Ischemic StrokePhase 2PASSPoRTNCT03979781
Personalized Antiplatelet Secondary Stroke PRevenTion
A Phase 2 study testing tailored antiplatelet selection in people with Ischemic Stroke and TIA, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Stroke, TIA
- What is being tested?
- tailored antiplatelet selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 9 May 2023
- Phase
- Phase 2
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13202
About this study
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
This is a descriptive study designed to evaluate the safety and feasibility of a precision medicine approach to antiplatelet selection for secondary stroke prevention.
Read the 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).
- Conditions
- Ischemic Stroke, TIA
- Being tested
- tailored antiplatelet selection, standard of care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored antiplatelet selectionDrug
antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes
standard of careDrug
antiplatelet selection using standard of care
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Intervention group Receives: Drug: tailored antiplatelet selection |
| Control Group | Active comparator | Standard of Care group Receives: Drug: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment and Platelet Reactivity
ability to recruit participants and achieve platelet reactivity target using platelet function assays
Measured: 90 days
Safety - Bleeding Complications
bleeding questionnaire
Measured: 90 days
Safety - Bleeding Complications
bleeding questionnaire
Measured: 1 year
Secondary outcomes (2)
Patient-centered Outcomes - Satisfaction
consumer assessment of healthcare providers and systems
Measured: 90 days
Patient-centered Outcomes - Satisfaction
consumer assessment of healthcare providers and systems
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start11 Jun 2018
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen C Albright, PhD, DO, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979781
- Sponsor's protocol ID
- 1158092
- Acronym
- PASSPoRT
- Status last verified
- Dec 2023
- First submitted
- 18 Mar 2019
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03979781
- Acronym / sponsor ID
- PASSPoRT / 1158092
- Conditions
- Ischemic Stroke, TIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 7 Jun 2019 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: tailored antiplatelet selectionIntervention group |
| Control Group | Active comparator | Drug: standard of careStandard of Care group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tailored antiplatelet selectionantiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes | Drug | Treatment Group |
| standard of careantiplatelet selection using standard of care | Drug | Control Group |
Primary outcome
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
2 secondary outcomes
Patient-centered Outcomes - Satisfaction
Time frame: 90 days
Patient-centered Outcomes - Satisfaction
Time frame: 1 year
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 15 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Karen C Albright, PhD, DO principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tailored antiplatelet selection in people with Ischemic Stroke and TIA, run by State University of New York - Upstate Medical University at 1 site in United States.
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 30 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 15 Dec 2023. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility - Recruitment and Platelet Reactivity (time frame: 90 days). The study lists 3 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 15 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.