Trial Outcomes & Findings for Chronic Kidney Disease (CKD) Platelet Study (NCT NCT03649711)
NCT ID: NCT03649711
Last Updated: 2022-12-29
Results Overview
We will use summary statistics to describe the distribution of the data. Post-treatment ADP-induced WBPA value in ohms (Ω) will be the primary outcome variable. We will use an analysis of covariance (ANCOVA) model to compare the treatment effects of ticagrelor vs. clopidogrel in CKD patients because this approach has higher statistical power than other methods to analyze drug effects. T
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
76 participants
Primary outcome timeframe
2 weeks
Results posted on
2022-12-29
Participant Flow
CKD recruitment. 50 patients signed consent and were randomized. Of those randomized, 1 received kidney transplant and 1 allergic reaction to clopidogrel and did not complete the study visits. 48 patients completed study visits. Non-CKD control recruitment: 26 signed consent and completed study visits.
Goal 48 CKD who complete visits; we ended up consenting and randomizing 50 CKD patients. Enrolled 26 to achieve goal. actual enrollment 50+26 = 76
Participant milestones
| Measure |
Experimental: CKD-Ticagrelor
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81mg/d
|
Arm: Active Comparator: CKD-Clopidogrel
Clopidogrel 75mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
|
Non-CKD Control Arm: Active Comparator: Control-ticagrelor
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d in subjects recruited without CKD
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
26
|
|
Overall Study
COMPLETED
|
25
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental: CKD-Ticagrelor
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81mg/d
|
Arm: Active Comparator: CKD-Clopidogrel
Clopidogrel 75mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
|
Non-CKD Control Arm: Active Comparator: Control-ticagrelor
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d in subjects recruited without CKD
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Kidney Transplant
|
1
|
0
|
0
|
Baseline Characteristics
Chronic Kidney Disease (CKD) Platelet Study
Baseline characteristics by cohort
| Measure |
Experimental: CKD-Ticagrelor
n=25 Participants
Ticagrelor 90mg Twice daily (double blind, random assignment) + aspirin 81 mg/d
|
Active Comparator: CKD-Clopidogrel
n=23 Participants
Clpidogrel 75 mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) aspirin 81 mg/d
|
Non-CKD Control Arm - Active Comparator: Control-ticagrelor
n=26 Participants
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d in subjects without CKD
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 15.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
3 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanics
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Body mass index
|
34.5 kg/m^2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
32.5 kg/m^2
STANDARD_DEVIATION 9.1 • n=7 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
33.5 kg/m^2
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Diabetes mellitus, n (%)
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Statin use, n (%)
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Baseline use of aspirin, n (%)
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Serum creatinine
|
4.2 mg/dl
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.3 mg/dl
STANDARD_DEVIATION 1.8 • n=7 Participants
|
0.9 mg/dl
STANDARD_DEVIATION 0.1 • n=5 Participants
|
4.2 mg/dl
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
eGFR
|
16.7 mL/min/1.73 m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
16.4 mL/min/1.73 m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
89.6 mL/min/1.73 m^2
STANDARD_DEVIATION 13.2 • n=5 Participants
|
16.5 mL/min/1.73 m^2
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Urine albumin-to-creatinine ratio
|
1,039.0 mg/g of creatinine
n=5 Participants
|
2,400.0 mg/g of creatinine
n=7 Participants
|
0 mg/g of creatinine
n=5 Participants
|
1,229.4 mg/g of creatinine
n=4 Participants
|
|
Hemoglobin
|
11.1 g/dl
STANDARD_DEVIATION 1.8 • n=5 Participants
|
11.1 g/dl
STANDARD_DEVIATION 1.9 • n=7 Participants
|
13.5 g/dl
STANDARD_DEVIATION 1.3 • n=5 Participants
|
13.5 g/dl
STANDARD_DEVIATION 1.3 • n=4 Participants
|
|
White blood cell count
|
7.7 1000 cells per µL
STANDARD_DEVIATION 2.4 • n=5 Participants
|
7.5 1000 cells per µL
STANDARD_DEVIATION 2.4 • n=7 Participants
|
6.2 1000 cells per µL
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.6 1000 cells per µL
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Platelet count
|
243.07 1000 cells per µL
STANDARD_DEVIATION 71.1 • n=5 Participants
|
229.9 1000 cells per µL
STANDARD_DEVIATION 49.7 • n=7 Participants
|
266.5 1000 cells per µL
STANDARD_DEVIATION 57.9 • n=5 Participants
|
236.7 1000 cells per µL
STANDARD_DEVIATION 61.5 • n=4 Participants
|
|
Percent of Hemoglobin A1c
|
6.9 percentage of hemoglobin
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.0 percentage of hemoglobin
STANDARD_DEVIATION 1.9 • n=7 Participants
|
5.3 percentage of hemoglobin
STANDARD_DEVIATION 0.4 • n=5 Participants
|
6.9 percentage of hemoglobin
STANDARD_DEVIATION 1.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: CKD groups were analyzed between randomized arms using ANCOVA. CK-ticagrelor arm was compared to control ticagrelor arm using Wilcoxon rank sum test.
We will use summary statistics to describe the distribution of the data. Post-treatment ADP-induced WBPA value in ohms (Ω) will be the primary outcome variable. We will use an analysis of covariance (ANCOVA) model to compare the treatment effects of ticagrelor vs. clopidogrel in CKD patients because this approach has higher statistical power than other methods to analyze drug effects. T
Outcome measures
| Measure |
CKD-Ticagrelor
n=25 Participants
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81 mg/d
Ticagrelor 90mg: Ticagrelor Pill
Aspirin 81 mg: Aspirin Pill
|
CKD-Clopidogrel
n=23 Participants
Clopidogrel 75 mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
Clopidogrel 75mg: Clopidogrel Pill and a matching placebo to conceal frequency
Aspirin 81 mg: Aspirin Pill
|
Control-ticagrelor
n=26 Participants
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d
Ticagrelor 90mg: Ticagrelor Pill
Aspirin 81 mg: Aspirin Pill
|
|---|---|---|---|
|
ADP Induced Platelet Aggregation
|
0 ohms
Interval 0.0 to 2.0
|
6 ohms
Interval 1.0 to 10.5
|
1 ohms
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: CKD groups were analyzed between randomized arms using ANCOVA. CK-ticagrelor arm was compared to control ticagrelor arm using Wilcoxon rank sum test.
Platelet surface P-selectin expression was measured using flow cytometry before and after treatment.
Outcome measures
| Measure |
CKD-Ticagrelor
n=25 Participants
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81 mg/d
Ticagrelor 90mg: Ticagrelor Pill
Aspirin 81 mg: Aspirin Pill
|
CKD-Clopidogrel
n=23 Participants
Clopidogrel 75 mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
Clopidogrel 75mg: Clopidogrel Pill and a matching placebo to conceal frequency
Aspirin 81 mg: Aspirin Pill
|
Control-ticagrelor
n=26 Participants
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d
Ticagrelor 90mg: Ticagrelor Pill
Aspirin 81 mg: Aspirin Pill
|
|---|---|---|---|
|
Platelet Surface P-selectin Expression
|
1002.5 Fluorescence intensity
Interval 758.5 to 1149.5
|
1037.5 Fluorescence intensity
Interval 848.5 to 1262.75
|
1052 Fluorescence intensity
Interval 810.0 to 1279.0
|
Adverse Events
Experimental: CKD-Ticagrelor
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm: Active Comparator: CKD-Clopidogrel
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm: Active Comparator: Control-ticagrelor
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: CKD-Ticagrelor
n=25 participants at risk
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81mg/d
|
Arm: Active Comparator: CKD-Clopidogrel
n=23 participants at risk
Clopidogrel 75mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
|
Arm: Active Comparator: Control-ticagrelor
n=26 participants at risk
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hospitalization
|
4.0%
1/25 • Number of events 1 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
0.00%
0/23 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
0.00%
0/26 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
Other adverse events
| Measure |
Experimental: CKD-Ticagrelor
n=25 participants at risk
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81mg/d
|
Arm: Active Comparator: CKD-Clopidogrel
n=23 participants at risk
Clopidogrel 75mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
|
Arm: Active Comparator: Control-ticagrelor
n=26 participants at risk
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Bruise
|
48.0%
12/25 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
39.1%
9/23 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
50.0%
13/26 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
|
Cardiac disorders
Dyspnea
|
20.0%
5/25 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
4.3%
1/23 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
3.8%
1/26 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
|
General disorders
Fatigue
|
8.0%
2/25 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
17.4%
4/23 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
0.00%
0/26 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
|
Gastrointestinal disorders
Acidity
|
0.00%
0/25 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
4.3%
1/23 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
7.7%
2/26 • Adverse events reported during the 2 weeks of treatment from baseline visit to the final visit
|
Additional Information
Dr. Nishank Jain, Associate Professor of Medicine
University of Arkansas for Medical Sciences
Phone: 5016865295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place