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Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement

Study acronym: Tissue-Valve
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: May 22, 2026 Enrollment target: 56 to 70 · Secondary endpoints: 1 to 2 · Primary endpoint revisedv8 Show 3 more changesShow less
    • Enrollment target: 56 to 70
    • Secondary endpoints: 1 to 2
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study completion date changed from estimate of Dec 2009 to Mar 2011 Trial status: Active, Not Recruiting to Completed · Enrollment target: estimated 60 to confirmed 56 · Primary completion date: Dec 2007v7 Show 3 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 60 to confirmed 56
    • Primary completion date: Dec 2007
  3. Trial status: Recruiting to Active, Not Recruiting Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  4. Completion date: Dec 2008 to Dec 2009v5
  5. Eligibility criteria revised Primary endpoint revised · Study description revised · Study title expanded, about 2 wordsv4 Show 3 more changesShow less
    • Primary endpoint revised
    • Study description revised
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Study arms: 0 to 2v3
  2. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used at University of Ottawa Heart Institute for the first three months after surgery in low-risk patients undergoing aortic valve replacement with a bioprosthetic valve: 1) daily use of high-dose aspirin \[325 mgs\], and 2) the combination of oral Warfarin \[target INR 2.0 to 3.0\] and low-dose aspirin \[81 mg\].
Trial Details
NCT Number NCT00465218
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Edwards Lifesciences
Conditions Aortic Valve Disease
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov