Trial Outcomes & Findings for Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia (NCT NCT02230527)
NCT ID: NCT02230527
Last Updated: 2021-07-07
Results Overview
The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
46 participants
Primary outcome timeframe
6 months
Results posted on
2021-07-07
Participant Flow
Participant milestones
| Measure |
Clopidogrel
Clopidogrel 75mg by mouth daily
Clopidogrel: 75mg once a day by mouth
|
Ticagrelor
Ticagrelor 90mg by mouth twice daily
Ticagrelor: 90mg twice a day by mouth
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Clopidogrel
Clopidogrel 75mg by mouth daily
Clopidogrel: 75mg once a day by mouth
|
Ticagrelor
Ticagrelor 90mg by mouth twice daily
Ticagrelor: 90mg twice a day by mouth
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
Baseline characteristics by cohort
| Measure |
Clopidogrel
n=23 Participants
Clopidogrel 75mg by mouth daily
Clopidogrel: 75mg once a day by mouth
|
Ticagrelor
n=23 Participants
Ticagrelor 90mg by mouth twice daily
Ticagrelor: 90mg twice a day by mouth
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Past/Current Smoker
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
History of Hypertension
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
History of Diabetes
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
History of Hyperlipidemia
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patients with baseline and TCPO2 data available at 6 months
The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.
Outcome measures
| Measure |
Clopidogrel
n=16 Participants
Clopidogrel 75mg by mouth daily
Clopidogrel: 75mg once a day by mouth
|
Ticagrelor
n=15 Participants
Ticagrelor 90mg by mouth twice daily
Ticagrelor: 90mg twice a day by mouth
|
|---|---|---|
|
Absolute Change in TcPO2 From Baseline to Month 6
|
14.9 mmHG
Standard Deviation 17.8
|
4.2 mmHG
Standard Deviation 19.9
|
Adverse Events
Clopidogrel
Serious events: 5 serious events
Other events: 3 other events
Deaths: 1 deaths
Ticagrelor
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clopidogrel
n=23 participants at risk
Clopidogrel 75mg by mouth daily
Clopidogrel: 75mg once a day by mouth
|
Ticagrelor
n=23 participants at risk
Ticagrelor 90mg by mouth twice daily
Ticagrelor: 90mg twice a day by mouth
|
|---|---|---|
|
Vascular disorders
Worsening Limb Ischemia
|
4.3%
1/23 • Number of events 2 • Through 6 months
Serious adverse events
|
13.0%
3/23 • Number of events 3 • Through 6 months
Serious adverse events
|
|
Vascular disorders
Limb pain/ulcer
|
8.7%
2/23 • Number of events 2 • Through 6 months
Serious adverse events
|
17.4%
4/23 • Number of events 4 • Through 6 months
Serious adverse events
|
|
Infections and infestations
infection
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
8.7%
2/23 • Number of events 2 • Through 6 months
Serious adverse events
|
|
General disorders
Organ failure
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
|
Surgical and medical procedures
Amputation
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
8.7%
2/23 • Number of events 2 • Through 6 months
Serious adverse events
|
|
Cardiac disorders
Stent occlusion
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
Other adverse events
| Measure |
Clopidogrel
n=23 participants at risk
Clopidogrel 75mg by mouth daily
Clopidogrel: 75mg once a day by mouth
|
Ticagrelor
n=23 participants at risk
Ticagrelor 90mg by mouth twice daily
Ticagrelor: 90mg twice a day by mouth
|
|---|---|---|
|
Renal and urinary disorders
UTI
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
|
Cardiac disorders
Junctional rhythm
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
30.4%
7/23 • Number of events 7 • Through 6 months
Serious adverse events
|
|
Vascular disorders
Foot ulcer
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
|
Vascular disorders
Excessive bruising
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/23 • Through 6 months
Serious adverse events
|
4.3%
1/23 • Number of events 1 • Through 6 months
Serious adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place