Trial Outcomes & Findings for Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis (NCT NCT02335099)
NCT ID: NCT02335099
Last Updated: 2022-06-08
Results Overview
Number of Participants with prolonged bleeding (\>30 minutes) after removal of needles
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
6 months
Results posted on
2022-06-08
Participant Flow
10 of 54 consented subjects failed screening and were not assigned to the study arms.
Participant milestones
| Measure |
Treatment
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
Placebo drug to be given twice a day for 6 months
|
|---|---|---|
|
Treatment
STARTED
|
22
|
22
|
|
Treatment
COMPLETED
|
17
|
17
|
|
Treatment
NOT COMPLETED
|
5
|
5
|
|
Follow-up
STARTED
|
17
|
17
|
|
Follow-up
COMPLETED
|
17
|
16
|
|
Follow-up
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
Placebo drug to be given twice a day for 6 months
|
|---|---|---|
|
Treatment
Withdrawal by Subject
|
1
|
3
|
|
Treatment
Lost to Follow-up
|
2
|
0
|
|
Treatment
Death
|
1
|
0
|
|
Treatment
Adverse Event
|
1
|
2
|
|
Follow-up
Death
|
0
|
1
|
Baseline Characteristics
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
Baseline characteristics by cohort
| Measure |
Treatment
n=17 Participants
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
n=17 Participants
Placebo drug to be given twice a day for 6 months
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 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
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 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: 6 monthsNumber of Participants with prolonged bleeding (\>30 minutes) after removal of needles
Outcome measures
| Measure |
Treatment
n=17 Participants
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
n=17 Participants
Placebo drug to be given twice a day for 6 months
|
|---|---|---|
|
Feasibility and Safety of Ticagrelor in Hemodialysis Patients
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage of participants with stenosis free survival
Outcome measures
| Measure |
Treatment
n=17 Participants
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
n=17 Participants
Placebo drug to be given twice a day for 6 months
|
|---|---|---|
|
Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access
|
72.2 percentage of participants
Interval 54.2 to 96.2
|
75.0 percentage of participants
Interval 56.5 to 99.5
|
Adverse Events
Treatment
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment
n=17 participants at risk
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
n=17 participants at risk
Placebo drug to be given twice a day for 6 months
|
|---|---|---|
|
Cardiac disorders
cardiac arrest
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/17 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Treatment
n=17 participants at risk
90 mg of Ticagrelor to be given orally twice a day for 6 months
|
Placebo
n=17 participants at risk
Placebo drug to be given twice a day for 6 months
|
|---|---|---|
|
Gastrointestinal disorders
increased diarrhea
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Blood and lymphatic system disorders
transient ischemic attack - stroke
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
General disorders
tickling feeling in head
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
General disorders
bruise on hand
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Blood and lymphatic system disorders
bloody drops on penis
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Infections and infestations
cold
|
0.00%
0/17 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
worsening pulmonary hypertension
|
0.00%
0/17 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place