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

Study acronym: PROMISE-BD-100
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2026 → Dec 31, 2026
See other at-risk trials from Ludwig-Maximilians - University of Munich

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jun 30, 2026 to Dec 31, 2026
    • Study completion pushed from Sep 30, 2026 to Mar 31, 2027
    • Eligibility criteria shortened, about 6 words
    v4
  2. Notable Primary completion date: May 31, 2025 to Jun 30, 2026
    • Study completion date: Aug 31, 2025 to Sep 30, 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2023 to Mar 1, 2023
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06121336
Lead Sponsor Ludwig-Maximilians - University of Munich
Conditions
(from sponsor)
Stroke, Stroke, Acute, Stroke, Ischemic, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Brain Ischemia, Nervous System Diseases
Related terms Brain Diseases, Brain Injuries, Brain Ischemia, Central Nervous System Diseases, Cerebrovascular Disorders, Ischemic Stroke, Nervous System Diseases, Stroke
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov