Trial Outcomes & Findings for Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) (NCT NCT02486367)
NCT ID: NCT02486367
Last Updated: 2022-07-20
Results Overview
Platelet reactivity will be measured and reported as platelet reactivity units (PRU) using the VerifyNow system.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Day 0,1,7,&30
Results posted on
2022-07-20
Participant Flow
Participant milestones
| Measure |
Standard Care/Clopidogrel
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)
Baseline characteristics by cohort
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Continuous
|
86 years
n=5 Participants
|
85 years
n=7 Participants
|
86 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Platelet reactivity will be measured and reported as platelet reactivity units (PRU) using the VerifyNow system.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Platelet Reactivity
Day 0
|
275.5 Platelet Reactivity Units
Standard Deviation 88.712
|
251 Platelet Reactivity Units
Standard Deviation 78.725
|
|
Platelet Reactivity
Day 1
|
234 Platelet Reactivity Units
Standard Deviation 80.956
|
128.5 Platelet Reactivity Units
Standard Deviation 59.787
|
|
Platelet Reactivity
Day 7
|
208 Platelet Reactivity Units
Standard Deviation 70.612
|
80 Platelet Reactivity Units
Standard Deviation 89.424
|
|
Platelet Reactivity
Day 30
|
183 Platelet Reactivity Units
Standard Deviation 60.044
|
134.5 Platelet Reactivity Units
Standard Deviation 79.943
|
SECONDARY outcome
Timeframe: Day 0,1,7&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
The percentage of inflammatory (CD14+CD16+) monocytes as a proportion of total monocytes will be measured using flow cytometry on whole blood.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Inflammatory Monocyte Proportion
Day 0
|
21.55103 percentage of inflammatory monocyte
Standard Deviation 10.59286
|
21.50033 percentage of inflammatory monocyte
Standard Deviation 10.45851
|
|
Inflammatory Monocyte Proportion
Day 1
|
22.23356 percentage of inflammatory monocyte
Standard Deviation 9.344043
|
25.12275 percentage of inflammatory monocyte
Standard Deviation 7.009391
|
|
Inflammatory Monocyte Proportion
Day 7
|
17.98342 percentage of inflammatory monocyte
Standard Deviation 9.791872
|
21.626 percentage of inflammatory monocyte
Standard Deviation 7.456207
|
|
Inflammatory Monocyte Proportion
Day 30
|
17.93496 percentage of inflammatory monocyte
Standard Deviation 6.183553
|
21.06446 percentage of inflammatory monocyte
Standard Deviation 7.326653
|
SECONDARY outcome
Timeframe: Day 0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Change in D-Dimer Levels as Measured by Blood Test
Day 0
|
1564.668 ng/mL
Standard Deviation 1070.615
|
1377.07 ng/mL
Standard Deviation 129.768
|
|
Change in D-Dimer Levels as Measured by Blood Test
Day 1
|
2851.912 ng/mL
Standard Deviation 2024.33
|
2961.475 ng/mL
Standard Deviation 2766.249
|
|
Change in D-Dimer Levels as Measured by Blood Test
Day 7
|
2653.55 ng/mL
Standard Deviation 1791.394
|
2635.958 ng/mL
Standard Deviation 924.744
|
|
Change in D-Dimer Levels as Measured by Blood Test
Day 30
|
1869.85 ng/mL
Standard Deviation 1255.566
|
1554.43 ng/mL
Standard Deviation 1641.397
|
SECONDARY outcome
Timeframe: Day 0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Change in sCD14 as Measured by Blood Test.
Day 0
|
1638.721 pg/mL
Standard Deviation 495.8533
|
1712.943 pg/mL
Standard Deviation 515.0831
|
|
Change in sCD14 as Measured by Blood Test.
Day 1
|
1713.16 pg/mL
Standard Deviation 657.8828
|
1896.489 pg/mL
Standard Deviation 662.1276
|
|
Change in sCD14 as Measured by Blood Test.
Day 7
|
1765.934 pg/mL
Standard Deviation 682.0759
|
1958.013 pg/mL
Standard Deviation 734.3658
|
|
Change in sCD14 as Measured by Blood Test.
Day 30
|
1525.929 pg/mL
Standard Deviation 527.5103
|
2077.568 pg/mL
Standard Deviation 628.0957
|
SECONDARY outcome
Timeframe: Day 0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Change in IL-6 as Measured by Blood Test.
Day 0
|
4.761 pg/mL
Standard Deviation 7.661641
|
4.4 pg/mL
Standard Deviation 7.997584
|
|
Change in IL-6 as Measured by Blood Test.
Day 1
|
43.127 pg/mL
Standard Deviation 27.41416
|
52.125 pg/mL
Standard Deviation 27.70069
|
|
Change in IL-6 as Measured by Blood Test.
Day 7
|
7.603 pg/mL
Standard Deviation 49.1147
|
7.18502 pg/mL
Standard Deviation 8.923163
|
|
Change in IL-6 as Measured by Blood Test.
Day 30
|
5.0825 pg/mL
Standard Deviation 3.660653
|
4.511 pg/mL
Standard Deviation 6.448078
|
SECONDARY outcome
Timeframe: Day0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Change in IL-8 as Measured by Blood Test
Day 0
|
6.841063 pg/mL
Standard Deviation 4.757768
|
4.837371 pg/mL
Standard Deviation 5.069666
|
|
Change in IL-8 as Measured by Blood Test
Day 1
|
8.58 pg/mL
Standard Deviation 7.281141
|
7.558923 pg/mL
Standard Deviation 12.75654
|
|
Change in IL-8 as Measured by Blood Test
Day 7
|
4.98 pg/mL
Standard Deviation 4.7204
|
4.584426 pg/mL
Standard Deviation 5.476614
|
|
Change in IL-8 as Measured by Blood Test
Day 30
|
4.81 pg/mL
Standard Deviation 4.04262
|
3.783523 pg/mL
Standard Deviation 6.472542
|
SECONDARY outcome
Timeframe: Day 0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=30 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Change in Mono-CD62P as Measured by Blood Test
Day 0
|
1.675 percentage of monocytes
Standard Deviation 4.43711
|
1.525 percentage of monocytes
Standard Deviation 4.43853
|
|
Change in Mono-CD62P as Measured by Blood Test
Day 1
|
0.75 percentage of monocytes
Standard Deviation 2.47703
|
0.715 percentage of monocytes
Standard Deviation 1.82821
|
|
Change in Mono-CD62P as Measured by Blood Test
Day 7
|
0.69 percentage of monocytes
Standard Deviation 1.70967
|
0.73 percentage of monocytes
Standard Deviation 1.12174
|
|
Change in Mono-CD62P as Measured by Blood Test
Day 30
|
0.695 percentage of monocytes
Standard Deviation 0.4158
|
0.765 percentage of monocytes
Standard Deviation 0.70892
|
SECONDARY outcome
Timeframe: Day 0,1,7,&30Population: Primary focus was Day 1. Day 7 and 30 were voluntary- not all participants came back.
Outcome measures
| Measure |
Standard Care/Clopidogrel
n=29 Participants
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=29 Participants
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Change in Mono-2b3a as Measured by Blood Test
Day 0
|
2.27 percentage of monocytes
Standard Deviation 1.951142
|
1.45 percentage of monocytes
Standard Deviation 1.323815
|
|
Change in Mono-2b3a as Measured by Blood Test
Day 1
|
1.45 percentage of monocytes
Standard Deviation 2.310398
|
0.93 percentage of monocytes
Standard Deviation 1.215051
|
|
Change in Mono-2b3a as Measured by Blood Test
Day 7
|
0.615 percentage of monocytes
Standard Deviation 0.790469
|
1.23 percentage of monocytes
Standard Deviation 0.897987
|
|
Change in Mono-2b3a as Measured by Blood Test
Day 30
|
0.765 percentage of monocytes
Standard Deviation 2.268643
|
0.86 percentage of monocytes
Standard Deviation 1.522551
|
Adverse Events
Standard Care/Clopidogrel
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Ticagrelor
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care/Clopidogrel
n=30 participants at risk
300mg load followed by 75mg daily.
Clopidogrel: Standard ADP receptor blockade
|
Ticagrelor
n=30 participants at risk
180mg load followed by 90mg twice daily for 30 days.
Ticagrelor: High potency ADP receptor blockade
|
|---|---|---|
|
Blood and lymphatic system disorders
Major (TIMI3a or above) bleeding event
|
16.7%
5/30 • Number of events 5 • 30days
|
16.7%
5/30 • Number of events 5 • 30days
|
|
Cardiac disorders
Permanent pacemaker placement
|
20.0%
6/30 • Number of events 6 • 30days
|
10.0%
3/30 • Number of events 3 • 30days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Zidar
University Hospitals Cleveland Medical Center
Phone: 216-791-3800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place