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Efficacy of Clopidogrel on Incidence of Silent Brain Infarction

Study acronym: ECISBI
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion pushed from Jul 1, 2026 to Dec 1, 2026 Study description expanded, about 8 words · Eligibility criteria shortened, about 1 wordv16 Show 2 more changesShow less
    • Study description expanded, about 8 words
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 125 to confirmed 134 · Primary completion date: Apr 1, 2026 to May 1, 2026 · Completion date: May 30, 2026 to Jul 1, 2026 · 1 morev15 Show 4 more changesShow less
    • Enrollment target: estimated 125 to confirmed 134
    • Primary completion date: Apr 1, 2026 to May 1, 2026
    • Completion date: May 30, 2026 to Jul 1, 2026
    • Site details revised
  3. Notable Primary completion date: Apr 30, 2025 to Apr 1, 2026 Enrollment target: 152 to 125 · Completion date: May 30, 2025 to May 30, 2026v14 Show 2 more changesShow less
    • Enrollment target: 152 to 125
    • Completion date: May 30, 2025 to May 30, 2026
  4. Minor Eligibility criteria revisedv13 See this version in full on ClinicalTrials.gov ↗
  5. Minor Primary completion date: Mar 31, 2025 to Apr 30, 2025 Completion date: Apr 30, 2025 to May 30, 2025 · Site details revised · Eligibility criteria expanded, about 1 wordv12 Show 3 more changesShow less
    • Completion date: Apr 30, 2025 to May 30, 2025
    • Site details revised
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 10 earlier versionsHide 10 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2022 to Mar 30, 2022 · Site details revisedv11 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2022 to Mar 30, 2022
    • Site details revised
  2. Minor Start date: Jan 31, 2022 to Mar 1, 2022v10
  3. Notable Start date: Nov 30, 2021 to Jan 31, 2022 Primary completion date: Feb 28, 2025 to Mar 31, 2025v9 Show 1 more changeShow less
    • Primary completion date: Feb 28, 2025 to Mar 31, 2025
  4. Notable Start date: Oct 20, 2021 to Nov 30, 2021v8
  5. Minor Start date: Sep 30, 2021 to Oct 20, 2021v7
  6. Notable Start date: Jul 30, 2021 to Sep 30, 2021 Primary completion date: Jan 31, 2025 to Feb 28, 2025 · Completion date: Feb 28, 2025 to Apr 30, 2025v6 Show 2 more changesShow less
    • Primary completion date: Jan 31, 2025 to Feb 28, 2025
    • Completion date: Feb 28, 2025 to Apr 30, 2025
  7. Notable Start date: Jun 18, 2021 to Jul 30, 2021v5
  8. Notable Start date: May 1, 2021 to Jun 18, 2021v4
  9. Notable Start date: Apr 1, 2021 to May 1, 2021v3
  10. Notable Start date: Feb 1, 2021 to Apr 1, 2021 Primary completion date: Nov 29, 2024 to Jan 31, 2025 · Completion date: Dec 31, 2024 to Feb 28, 2025v2 Show 2 more changesShow less
    • Primary completion date: Nov 29, 2024 to Jan 31, 2025
    • Completion date: Dec 31, 2024 to Feb 28, 2025
  1. 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.
Silent brain infarctions (SBIs) are a manifestation of covert cerebrovascular disease, without obvious clinical deficit, noted very often in patients presenting with a new stroke or new transient ischemic attack. SBIs are linked to a significant increase in risk for subsequent stroke and cognitive decline. However, no biomarker is currently available that can predict the recurrence of these subclinical lesions. Coated-platelets are a measure of platelet procoagulant potential significantly increased in patients with ischemic stroke or transient ischemic attack compared to unaffected controls. Higher coated-platelet levels are strongly associated with both the presence and number of SBIs. Among medications approved for preventing stroke recurrence, the investigators identified clopidogrel as a pharmacological agent leading to a decrease in coated-platelet levels. In this project, the investigators plan to evaluate if clopidogrel can decrease the rate of occurrence of new silent brain infarctions. The result will enhance the investigators understanding of the relationship between platelets and silent brain infarcts, leading to improved health care delivery and also potential targets for novel preventive pharmacological interventions.
Trial Details
NCT Number NCT04698031
Lead Sponsor VA Office of Research and Development
Conditions Silent Brain Infarction
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov