Trial Outcomes & Findings for Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes (NCT NCT02325466)
NCT ID: NCT02325466
Last Updated: 2022-03-21
Results Overview
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline
COMPLETED
PHASE3
70 participants
baseline, week 16
2022-03-21
Participant Flow
Recruitment from April 2015 to April 2018. Study participants were recruited from the outpatient cardiology practice and the Cardiac Catheterization database at the Mount Sinai Hospital, New York, NY, USA.
Participant milestones
| Measure |
Aspirin/Ticagrelor Placebo
aspirin 81 mg daily and ticagrelor placebo twice daily
crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Period 1 Timeframe - Baseline to Week 4
STARTED
|
23
|
23
|
24
|
|
Period 1 Timeframe - Baseline to Week 4
COMPLETED
|
22
|
21
|
21
|
|
Period 1 Timeframe - Baseline to Week 4
NOT COMPLETED
|
1
|
2
|
3
|
|
Period 2 - Timeframe Week 4 to Week 10
STARTED
|
22
|
21
|
21
|
|
Period 2 - Timeframe Week 4 to Week 10
COMPLETED
|
19
|
20
|
21
|
|
Period 2 - Timeframe Week 4 to Week 10
NOT COMPLETED
|
3
|
1
|
0
|
|
3rd Crossover - Week 10 to Week 16
STARTED
|
19
|
20
|
21
|
|
3rd Crossover - Week 10 to Week 16
COMPLETED
|
18
|
18
|
21
|
|
3rd Crossover - Week 10 to Week 16
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Aspirin/Ticagrelor Placebo
aspirin 81 mg daily and ticagrelor placebo twice daily
crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Period 1 Timeframe - Baseline to Week 4
Adverse Event
|
0
|
0
|
1
|
|
Period 1 Timeframe - Baseline to Week 4
Withdrawal by Subject
|
0
|
2
|
0
|
|
Period 1 Timeframe - Baseline to Week 4
urgent vascularization
|
1
|
0
|
2
|
|
Period 2 - Timeframe Week 4 to Week 10
Protocol Violation
|
1
|
0
|
0
|
|
Period 2 - Timeframe Week 4 to Week 10
Withdrawal by Subject
|
1
|
1
|
0
|
|
Period 2 - Timeframe Week 4 to Week 10
urgent vascularization
|
1
|
0
|
0
|
|
3rd Crossover - Week 10 to Week 16
Adverse Event
|
1
|
0
|
0
|
|
3rd Crossover - Week 10 to Week 16
Protocol Violation
|
0
|
1
|
0
|
|
3rd Crossover - Week 10 to Week 16
urgent vascularization
|
0
|
1
|
0
|
Baseline Characteristics
Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
All Participants
n=70 Participants
Two crossovers with all participants experiencing all 3 arms
|
|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Hematocrit
|
38.3 percent of cells
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Fibrinogen
|
351 mg/dL
STANDARD_DEVIATION 109 • n=5 Participants
|
|
Fasting glucose
|
124 mg/dL
STANDARD_DEVIATION 47 • n=5 Participants
|
|
Hemoglobin A1c
|
7.20 percentage of hemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Blood viscosity 300 s^-1
|
4.0 centipoises (cPs)
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Blood viscosity 5 s^-1
|
11.1 cPs
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 16Population: data collected and included for any participants who return for any of their visits.
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline
Outcome measures
| Measure |
Aspirin/Ticagrelor Placebo
n=60 Participants
aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
n=61 Participants
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
n=58 Participants
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Mean Change in Low Shear Blood Viscosity
|
1.045 5 s^-1 cPs
Standard Deviation 1.525
|
-1.793 5 s^-1 cPs
Standard Deviation 1.835
|
-1.759 5 s^-1 cPs
Standard Deviation 1.298
|
PRIMARY outcome
Timeframe: baseline and week 16Population: data collected and included for any participants who return for any of their visits.
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline
Outcome measures
| Measure |
Aspirin/Ticagrelor Placebo
n=60 Participants
aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
n=61 Participants
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
n=58 Participants
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Mean Change in High Shear Blood Viscosity
|
0.165 300 s^-1 cPs
Standard Deviation 0.318
|
-0.228 300 s^-1 cPs
Standard Deviation 0.469
|
-0.231 300 s^-1 cPs
Standard Deviation 0.360
|
SECONDARY outcome
Timeframe: baseline and week 16Population: data collected for participants who return for their visits.
Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index (ABI) and toe brachial index (TBI) at week 16 compared to baseline. ABI and TBI are taken in order to determine the existence and severity of peripheral arterial disease. ABI - The normal range for the ankle-brachial index is between 0.90 and 1.30. ABI \<0.90 is abnormal: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. The lower the index, the higher the chances of leg pain while exercising or limb-threatening low blood flow. TBI ≥ 0.7 is normal, TBI \< 0.7 is abnormal.
Outcome measures
| Measure |
Aspirin/Ticagrelor Placebo
n=60 Participants
aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
n=61 Participants
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
n=58 Participants
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Mean Change in Peripheral Arterial Blood Flow
ABI right side
|
0.038 index
Standard Deviation 0.055
|
0.021 index
Standard Deviation 0.019
|
0.095 index
Standard Deviation 0.051
|
|
Mean Change in Peripheral Arterial Blood Flow
ABI left side
|
0.015 index
Standard Deviation 0.067
|
0.032 index
Standard Deviation 0.038
|
0.075 index
Standard Deviation 0.029
|
|
Mean Change in Peripheral Arterial Blood Flow
TBI right side
|
0.044 index
Standard Deviation 0.013
|
0.009 index
Standard Deviation 0.015
|
0.011 index
Standard Deviation 0.008
|
|
Mean Change in Peripheral Arterial Blood Flow
TBI left side
|
0.004 index
Standard Deviation 0.022
|
-0.016 index
Standard Deviation 0.018
|
0.036 index
Standard Deviation 0.028
|
SECONDARY outcome
Timeframe: baseline and week 16Population: data collected for participants who return for their visits.
Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index and toe pressures composite score at week 16 from baseline. Composite score obtained by adding all the measurements and averaged. The score was tested by the Laser Doppler Flowmetry (LDF). Minimum score is 0 which mean no blood flow detected and there is no maximum value of the score, and higher score mean better blood flow.
Outcome measures
| Measure |
Aspirin/Ticagrelor Placebo
n=60 Participants
aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
n=61 Participants
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
n=58 Participants
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Mean Change in Microvascular Blood Flow Composite Score
Right side
|
-4.10 score on a scale
Standard Deviation 13.30
|
13.64 score on a scale
Standard Deviation 7.34
|
-5.23 score on a scale
Standard Deviation 7.76
|
|
Mean Change in Microvascular Blood Flow Composite Score
Left side
|
-5.60 score on a scale
Standard Deviation 11.86
|
24.76 score on a scale
Standard Deviation 8.36
|
-4.29 score on a scale
Standard Deviation 7.48
|
Adverse Events
Aspirin/Ticagrelor Placebo
Aspirin/Ticagrelor
Aspirin Placebo/Ticagrelor
Serious adverse events
| Measure |
Aspirin/Ticagrelor Placebo
n=70 participants at risk
aspirin 81 mg daily and ticagrelor placebo twice daily
crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
n=70 participants at risk
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
n=70 participants at risk
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Gastrointestinal disorders
GI Bleeding
|
0.00%
0/70 • 16 weeks
data collected for participants who return for any subsequent visits
|
1.4%
1/70 • 16 weeks
data collected for participants who return for any subsequent visits
|
0.00%
0/70 • 16 weeks
data collected for participants who return for any subsequent visits
|
Other adverse events
| Measure |
Aspirin/Ticagrelor Placebo
n=70 participants at risk
aspirin 81 mg daily and ticagrelor placebo twice daily
crossover order was never unblinded to PI and study team
|
Aspirin/Ticagrelor
n=70 participants at risk
aspirin 81 mg daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
Aspirin Placebo/Ticagrelor
n=70 participants at risk
aspirin placebo daily and ticagrelor 90 mg twice daily
crossover order was never unblinded to PI and study team
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/70 • 16 weeks
data collected for participants who return for any subsequent visits
|
0.00%
0/70 • 16 weeks
data collected for participants who return for any subsequent visits
|
1.4%
1/70 • 16 weeks
data collected for participants who return for any subsequent visits
|
Additional Information
Dr. Robert S. Rosenson
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER