NCT03979781CompletedPhase 2
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
State University of New York - Upstate Medical University1 site in 1 country90 target enrollmentStarted: June 11, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Safety - Bleeding Complications
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment Group
Experimental
Intervention group
Intervention: tailored antiplatelet selection (Drug)
Control Group
Active Comparator
Standard of Care group
Intervention: standard of care (Drug)
Outcomes
Primary Outcomes
Safety - Bleeding Complications
Time Frame: 1 year
bleeding questionnaire
Feasibility - Recruitment and Platelet Reactivity
Time Frame: 90 days
ability to recruit participants and achieve platelet reactivity target using platelet function assays
Secondary Outcomes
- Patient-centered Outcomes - Satisfaction(1 year)
Investigators
Study Sites (1)
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