Trial Outcomes & Findings for Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study (NCT NCT01768637)
NCT ID: NCT01768637
Last Updated: 2019-04-19
Results Overview
Citrated whole blood was used to measure platelet aggregation induced by agonist (arachidonic acid at 5 mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-04-19
Participant Flow
Participants were recruited from December 10, 2012 to January 31, 2014 from outpatient clinics at Parkland hospital, Dallas Veterans Affairs hospital and University of Texas Southwestern Medical Center, Dallas, TX, USA.
From 1,545 participants screened from outpatient clinics, 196 eligible patients were approached for enrollment, 128 refused and 48 signed consent.
Participant milestones
| Measure |
Chronic Kidney Disease
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
19
|
|
Overall Study
Completed Visit 1
|
28
|
16
|
|
Overall Study
Completed Visit 2
|
26
|
13
|
|
Overall Study
COMPLETED
|
26
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
|
Overall Study
Difficult blood draw
|
1
|
0
|
Baseline Characteristics
Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease
n=28 Participants
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
n=16 Participants
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 10 • n=99 Participants
|
49 years
STANDARD_DEVIATION 11 • n=107 Participants
|
51 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body mass index
|
32.0 kg/m^2
STANDARD_DEVIATION 5.5 • n=99 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 4.9 • n=107 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Diabetes mellitus
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Proton pump inhibitor use
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Beta blocker use
|
21 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Statin use
|
19 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker use
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Allopurinol use
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Baseline use of aspirin
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
estimated glomerular filtration rate (eGFR)
|
17 ml/min/1.73m^2
STANDARD_DEVIATION 7 • n=99 Participants
|
101 ml/min/1.73m^2
STANDARD_DEVIATION 15 • n=107 Participants
|
47.2 ml/min/1.73m^2
STANDARD_DEVIATION 42.3 • n=206 Participants
|
|
Urine albumin to creatinine ratio
|
1282 mg/g
n=99 Participants
|
5 mg/g
n=107 Participants
|
87 mg/g
n=206 Participants
|
|
Hemoglobin
|
11.2 g/dl
STANDARD_DEVIATION 1.7 • n=99 Participants
|
14.4 g/dl
STANDARD_DEVIATION 1.7 • n=107 Participants
|
12.5 g/dl
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
Hematocrit
|
33.9 percent of red blood cells in blood
STANDARD_DEVIATION 5.1 • n=99 Participants
|
42.6 percent of red blood cells in blood
STANDARD_DEVIATION 4.2 • n=107 Participants
|
36.9 percent of red blood cells in blood
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Platelet count
|
232 K per microL
STANDARD_DEVIATION 55 • n=99 Participants
|
217 K per microL
STANDARD_DEVIATION 55 • n=107 Participants
|
227 K per microL
STANDARD_DEVIATION 54.7 • n=206 Participants
|
|
Glycosylated hemoglobin
|
6.8 percent of glycated hemoglobin in blood
STANDARD_DEVIATION 0.4 • n=99 Participants
|
6.4 percent of glycated hemoglobin in blood
STANDARD_DEVIATION 0.4 • n=107 Participants
|
6.4 percent of glycated hemoglobin in blood
STANDARD_DEVIATION 1.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksCitrated whole blood was used to measure platelet aggregation induced by agonist (arachidonic acid at 5 mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment
Outcome measures
| Measure |
Chronic Kidney Disease
n=28 Participants
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
n=16 Participants
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
|---|---|---|
|
Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid
Baseline
|
21.0 ohms
Interval 10.5 to 24.5
|
18.0 ohms
Interval 10.0 to 20.0
|
|
Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid
visit 2
|
0 ohms
Interval 0.0 to 0.0
|
0 ohms
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 2 weeksCitrated whole blood was used to measure platelet aggregation induced by agonist (collagen at 2mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment
Outcome measures
| Measure |
Chronic Kidney Disease
n=28 Participants
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
n=16 Participants
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
|---|---|---|
|
Whole Blood Platelet Aggregation to 2 µg/mL Collagen
Baseline
|
28.5 ohms
Interval 23.5 to 31.5
|
25.0 ohms
Interval 20.0 to 30.0
|
|
Whole Blood Platelet Aggregation to 2 µg/mL Collagen
visit 2
|
19.5 ohms
Interval 16.0 to 26.0
|
19.0 ohms
Interval 16.0 to 22.0
|
SECONDARY outcome
Timeframe: 4 weeksCitrated whole blood was used to measure platelet aggregation induced by agonist (adenosine diphosphate at 20mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) and on aspirin (visit 2) was compared between groups with post treatment values (visit 3) after 2 weeks of aspirin and clopidogrel treatment
Outcome measures
| Measure |
Chronic Kidney Disease
n=28 Participants
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
n=16 Participants
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
|---|---|---|
|
Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate
visit 2
|
11.0 ohms
Interval 8.0 to 16.0
|
10.0 ohms
Interval 8.0 to 11.0
|
|
Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate
Baseline
|
13.5 ohms
Interval 9.5 to 16.0
|
9.0 ohms
Interval 6.0 to 12.0
|
|
Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate
visit 3
|
8.0 ohms
Interval 1.0 to 12.0
|
3.0 ohms
Interval 0.0 to 4.0
|
Adverse Events
Chronic Kidney Disease
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Normal Controls
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chronic Kidney Disease
n=28 participants at risk
Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
Normal Controls
n=16 participants at risk
Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.
Aspirin: Aspirin 81 mg by mouth daily
Clopidogrel: Clopidogrel 75 mg by mouth once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Brusing or nose bleed
|
17.9%
5/28 • Number of events 5 • Adverse events were collected throughout the period of the study visits for an average of 4 weeks.
not different
|
56.2%
9/16 • Number of events 9 • Adverse events were collected throughout the period of the study visits for an average of 4 weeks.
not different
|
Additional Information
Nishank Jain, MD
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