Personalized Antiplatelet Secondary Stroke PRevenTion

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University

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