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

Study acronym: Tissue-Valve
StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Results first posted: May 22, 2026
    • Enrollment target: 56 to 70
    • Secondary endpoints: 1 to 2
    • Primary endpoint revised
    v8
  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 2007
    v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  4. Study completion date: Dec 2008 to Dec 2009v5
  5. Eligibility criteria revised
    • Primary endpoint revised
    • Study description revised
    • Study title expanded, about 2 words
    v4
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  1. Study arms: 0 to 2v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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
(from sponsor)		 Aortic Valve Disease
Related terms Aortic Valve Disease, Intracranial Embolism, Thrombosis
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov