N/A
N=70
Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement
Aortic Valve Disease
Bottom Line
View on ClinicalTrials.gov: NCT00465218 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Differences in the Rate of Doppler-detected Cerebral Micro Emboli Between the Two Prophylactic Treatments of Thrombosis — 1.1; 0.7; 1.0; 0.7 MES counts
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prophylaxis of Thrombosis after aortic valve replacement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Heart Institute Research Corporation
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in the Rate of Doppler-detected Cerebral Micro Emboli Between the Two Prophylactic Treatments of Thrombosis |
1.1; 0.7; 1.0; 0.7; 2.1; 1.4 | — |
| SECONDARY Differences in the Degree of Inhibition of Platelet Aggregation Between the Two Prophylactic Treatments of Thrombosis |
101; 86; 174; 186 | — |
| SECONDARY Difference in the Degree of Inhibitor of Platelet Aggregation Between the Two Prophylactic Treatments of Thrombosis |
14; 18 | — |
Summary
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].
Eligibility Criteria
Inclusion Criteria
- Patients undergoing primary aortic valve replacement with bioprosthetic (tissue) valve.
Exclusion Criteria
- Emergency surgery or redo operations.
- Patients with history of transient ischemic attacks, stroke, or history of carotid stenosis greater than 50% as detected by carotid duplex doppler or angiography.
- Patients with COPD who are CO2 retainers.
- Patients with LV function less than 50%, or enlarged left ventricle greater than 50 mm as detected by echocardiography or previous history of thromboembolism.
- Patients with history of atrial fibrillation or heart rhythm disturbances.
Data sourced from ClinicalTrials.gov (NCT00465218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.