NCT03979781

Personalized Antiplatelet Secondary Stroke PRevenTion

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ischemic Stroke
• TIA

Interventions

Type	Name	Description
DRUG	tailored antiplatelet selection	antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes
DRUG	standard of care	antiplatelet selection using standard of care

Timeline

• Start date: 2018-06-11
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2019-06-07
• Last updated: 2023-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study