Clinical Trial

PRecisiOn Medicine In StrokE: Evolution of Plasma Brain-Derived Tau in Acute Stroke

Study acronym: PROMISE-BD-100
Recruiting
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Record status
This record was last updated September 4, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The investigators recently identified Brain-derived tau (BD-tau) as a sensitive blood-based biomarker for brain injury in acute ischemic stroke: in patients with acute ischemic stroke, plasma BD-tau was associated with imaging-based metrics of brain injury upon admission, increased within the first 24 hours in correlation with infarct progression, and at 24 hours was superior to final infarct volume in predicting 90-day functional outcome. While informing on the relation of BD-tau with imaging-based metrics of brain injury, this cross-sectional study was restricted to BD-tau assessments upon admission and at day 2 and could not inform on key characteristics of the evolution of plasma BD-tau, including when exactly it starts to rise, how long it continues to rise, and how it is determined by infarct characteristics as well as comorbidities. Here, the investigators aim to assess plasma BD-tau every hour from admission to 48 hours after onset to evaluate the hypothesis that BD-tau rises immediately after onset and plateaus between three and 48 hours after onset.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-02; most recent amendment 2025-09-02.
Status change: Not Yet Recruiting → Recruiting 2024-03-12
Trial Details
NCT Number NCT06121336
Lead Sponsor Ludwig-Maximilians - University of Munich
Conditions Stroke, Stroke, Acute, Stroke, Ischemic, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Brain Ischemia, Nervous System Diseases
Enrollment 100 participants
Start Date 2023-03-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-04