Trial Outcomes & Findings for Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR (NCT NCT02227368)
NCT ID: NCT02227368
Last Updated: 2017-07-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
26 Weeks
Results posted on
2017-07-19
Participant Flow
A total of 71 subjects were screened at 16 centers throughout the United States of America (USA). First subject enrolled: 20Oct2014. Last subject last visit: 23May2016. Date of early study termination: 21Oct2015
A total of 40 subjects were randomised. Thirty-one subjects were not randomised due to not meeting inclusion/exclusion criteria (20 subjects), withdrawing consent prior to randomisation (2 subjects), and other reasons (9 subjects) including not being able to return for randomisation within 48 hours of the qualifying revascularization.
Participant milestones
| Measure |
Ticagrelor
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
24
|
|
Overall Study
Sujects Who Received Treatment
|
16
|
24
|
|
Overall Study
Sujects Who Completed Treatment
|
10
|
17
|
|
Overall Study
COMPLETED
|
14
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Ticagrelor
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
|---|---|---|
|
Overall Study
No EVR/not PAD/PI decision/RLE bypass
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
Baseline characteristics by cohort
| Measure |
Ticagrelor
n=16 Participants
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
n=24 Participants
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
31 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: ITT population is the analysis population. Six subjects without evaluable baseline were excluded from the analysis.
Outcome measures
| Measure |
Ticagrelor
n=14 Participants
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
n=20 Participants
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
|---|---|---|
|
Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)
|
0.0 log(Second)
Interval -0.2 to 0.2
|
0.1 log(Second)
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: ITT population is the analysis population. Twelve subjects without evaluable baseline were excluded from the analysis.
Outcome measures
| Measure |
Ticagrelor
n=12 Participants
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
n=16 Participants
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
|---|---|---|
|
Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)
|
0.6 log(Second)
Interval 0.1 to 1.1
|
0.5 log(Second)
Interval 0.1 to 0.8
|
Adverse Events
Ticagrelor
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Aspirin
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor
n=16 participants at risk
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
n=24 participants at risk
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
6.2%
1/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
0.00%
0/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
4.2%
1/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
4.2%
1/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
0.00%
0/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
4.2%
1/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Vascular disorders
Haemorrhage
|
6.2%
1/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
0.00%
0/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
0.00%
0/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
4.2%
1/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
Other adverse events
| Measure |
Ticagrelor
n=16 participants at risk
Ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Aspirin
n=24 participants at risk
Aspirin 100mg once daily plus ticagrelor placebo twice a day
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
6.2%
1/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
0.00%
0/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/16 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
4.2%
1/24 • 26 weeks treatment period + 30 days followup
Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require Confidential Information to be removed and the sponsor can extend the embargo for an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER