Trial Outcomes & Findings for Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement (NCT NCT00465218)
NCT ID: NCT00465218
Last Updated: 2026-05-22
Results Overview
Trans-cranial doppler (TCD) measurements were used to test for the presence of cerebral micro-emboli. Doppler measurements were completed on the neck and throughout the temporal window. In addition, probes were secure to the temporal areas with a headband. Measurements determined presence of air or solid emboli. Each participant at the 1 month visit underwent TCD measurements after 30min of exposure to room air, and again 30min after receiving 100% oxygen through a breathing mask. Results show the comparison of participants on aspirin only vs warfarin + aspirin when TCD was completed both in room air and with 100% oxygen.
Recruitment status
COMPLETED
Target enrollment
70 participants
Primary outcome timeframe
1 month after surgery
Results posted on
2026-05-22
Participant Flow
Because all nonexcluded patients completed the study's procedures, the study was stopped after a total of 56 patients were enrolled and followed, with each arm of the study having 28 patients.
Participant milestones
| Measure |
Aspirin Only
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
33
|
|
Overall Study
Excluded post randomization
|
5
|
9
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Aspirin Only
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Overall Study
Post-operative atrial fibrillation
|
9
|
5
|
Baseline Characteristics
Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Aspirin Only
n=28 Participants
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
n=28 Participants
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 9 • n=2 Participants
|
71 years
STANDARD_DEVIATION 10 • n=4 Participants
|
71.5 years
STANDARD_DEVIATION 9.5 • n=6 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=2 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=2 Participants
|
19 Participants
n=4 Participants
|
40 Participants
n=6 Participants
|
|
Diabetes mellitus
|
9 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=6 Participants
|
|
Hypertension
|
21 Participants
n=2 Participants
|
17 Participants
n=4 Participants
|
38 Participants
n=6 Participants
|
|
Smoking
|
4 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=6 Participants
|
|
Heart Failure
|
14 Participants
n=2 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=6 Participants
|
|
Carotid artery stenosis <70%
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Vertebral artery stenosis
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Coagulopathy
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Thrombocytosis/thrombocytopenia
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Malignancy
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Type of surgery
bAVR only
|
16 Participants
n=2 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=6 Participants
|
|
Type of surgery
bAVR + CABG
|
12 Participants
n=2 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=6 Participants
|
|
Type of valve
Perimount
|
22 Participants
n=2 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=6 Participants
|
|
Type of valve
Hancock II
|
5 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=6 Participants
|
|
Type of valve
Mosaic
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Cardiopulmonary Bypass time
|
111 minutes
STANDARD_DEVIATION 27 • n=2 Participants
|
110 minutes
STANDARD_DEVIATION 42 • n=4 Participants
|
110.5 minutes
STANDARD_DEVIATION 35 • n=6 Participants
|
|
Aortic cross clamp time
|
85 minutes
STANDARD_DEVIATION 23 • n=2 Participants
|
78 minutes
STANDARD_DEVIATION 25 • n=4 Participants
|
81.5 minutes
STANDARD_DEVIATION 24 • n=6 Participants
|
|
Post operative complications - stroke/TIA
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Post operative complications - Bleeding, >3 units PRBCs transfused
|
4 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 1 month after surgeryPopulation: Analysis population includes participants that complete the study only. Patients that withdrew prior to the of the study assessments were not included.
Trans-cranial doppler (TCD) measurements were used to test for the presence of cerebral micro-emboli. Doppler measurements were completed on the neck and throughout the temporal window. In addition, probes were secure to the temporal areas with a headband. Measurements determined presence of air or solid emboli. Each participant at the 1 month visit underwent TCD measurements after 30min of exposure to room air, and again 30min after receiving 100% oxygen through a breathing mask. Results show the comparison of participants on aspirin only vs warfarin + aspirin when TCD was completed both in room air and with 100% oxygen.
Outcome measures
| Measure |
Aspirin Only
n=28 Participants
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
n=28 Participants
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Differences in the Rate of Doppler-detected Cerebral Micro Emboli Between the Two Prophylactic Treatments of Thrombosis
MES counts after room air - 30 min (all participants at 1 month)
|
1.1 MES counts
Standard Deviation 2.3
|
0.7 MES counts
Standard Deviation 1.1
|
|
Differences in the Rate of Doppler-detected Cerebral Micro Emboli Between the Two Prophylactic Treatments of Thrombosis
MES counts after 100% O2 - 30 min (all participants at 1month)
|
1.0 MES counts
Standard Deviation 2.4
|
0.7 MES counts
Standard Deviation 1.2
|
|
Differences in the Rate of Doppler-detected Cerebral Micro Emboli Between the Two Prophylactic Treatments of Thrombosis
Total MES counts (all participants at 1month)
|
2.1 MES counts
Standard Deviation 4.6
|
1.4 MES counts
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 1 month after surgeryOutcome measures
| Measure |
Aspirin Only
n=28 Participants
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
n=28 Participants
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Differences in the Degree of Inhibition of Platelet Aggregation Between the Two Prophylactic Treatments of Thrombosis
Platelet Function Analysis-ADP (sec)
|
101 seconds
Standard Deviation 54
|
86 seconds
Standard Deviation 24
|
|
Differences in the Degree of Inhibition of Platelet Aggregation Between the Two Prophylactic Treatments of Thrombosis
Platelet Function Analysis-EPI (sec)
|
174 seconds
Standard Deviation 72
|
186 seconds
Standard Deviation 66
|
SECONDARY outcome
Timeframe: 1 month after surgeryOutcome measures
| Measure |
Aspirin Only
n=28 Participants
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
n=28 Participants
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Difference in the Degree of Inhibitor of Platelet Aggregation Between the Two Prophylactic Treatments of Thrombosis
|
14 Percentage of P-Selectin Expression
Standard Deviation 7
|
18 Percentage of P-Selectin Expression
Standard Deviation 19
|
Adverse Events
Aspirin Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Warfarin Plus Aspirin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin Only
n=28 participants at risk
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
n=28 participants at risk
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/28
|
0.00%
0/28
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/28
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/28
|
0.00%
0/28
|
Other adverse events
| Measure |
Aspirin Only
n=28 participants at risk
High dose aspirin (325 mg)
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
Warfarin Plus Aspirin
n=28 participants at risk
Low dose aspirin (81 mgs) plus warfarin
Prophylaxis of Thrombosis after aortic valve replacement: Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
|
|---|---|---|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.00%
0/28
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place