Personalized Antiplatelet Secondary Stroke PRevenTion

NCT03979781 | Completed Phase 2 FDA Drug

• 1 other identifier: 1158092
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; TIA

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Patient-centered Outcomes - Satisfaction

  90 days

• Patient-centered Outcomes - Satisfaction

  1 year

Study Arms (2)

Treatment Group

EXPERIMENTAL

Intervention group

Drug: tailored antiplatelet selection

Control Group

ACTIVE COMPARATOR

Standard of Care group

Drug: standard of care

Interventions

tailored antiplatelet selection DRUG

antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes

Treatment Group

standard of care DRUG

antiplatelet selection using standard of care

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13202, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karen C Albright, PhD, DO

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: June 7, 2019
• Study Start: June 11, 2018
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)