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Trial record 46 of 619 for:    ASPIRIN AND clopidogrel

Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study (WiCKDonASA)

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ClinicalTrials.gov Identifier: NCT01768637
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Kidney Disease
Interventions Drug: Aspirin
Drug: Clopidogrel
Enrollment 48
Recruitment Details 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.
Pre-assignment Details From 1,545 participants screened from outpatient clinics, 196 eligible patients were approached for enrollment, 128 refused and 48 signed consent.
Arm/Group Title Chronic Kidney Disease Normal Controls
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started [1] 29 19
Completed Visit 1 28 16
Completed Visit 2 26 13
Completed [2] 26 12
Not Completed 3 7
Reason Not Completed
Lost to Follow-up             2             7
Difficult blood draw             1             0
[1]
Signed consent
[2]
completed visit 3
Arm/Group Title Chronic Kidney Disease Normal Controls Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 28 16 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 16 participants 44 participants
52  (10) 49  (11) 51  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
Female
12
  42.9%
8
  50.0%
20
  45.5%
Male
16
  57.1%
8
  50.0%
24
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
Hispanic or Latino
8
  28.6%
4
  25.0%
12
  27.3%
Not Hispanic or Latino
20
  71.4%
12
  75.0%
32
  72.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  53.6%
4
  25.0%
19
  43.2%
White
13
  46.4%
12
  75.0%
25
  56.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 28 participants 16 participants 44 participants
32.0  (5.5) 29.8  (4.9) 31.2  (5.3)
Diabetes mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
13 7 20
Proton pump inhibitor use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
1
   3.6%
1
   6.3%
2
   4.5%
Beta blocker use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
21
  75.0%
0
   0.0%
21
  47.7%
Statin use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
19
  67.9%
5
  31.3%
24
  54.5%
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
12
  42.9%
5
  31.3%
17
  38.6%
Allopurinol use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
6
  21.4%
0
   0.0%
6
  13.6%
Baseline use of aspirin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
12
  42.9%
4
  25.0%
16
  36.4%
estimated glomerular filtration rate (eGFR)  
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73m^2
Number Analyzed 28 participants 16 participants 44 participants
17  (7) 101  (15) 47.2  (42.3)
Urine albumin to creatinine ratio  
Median (Inter-Quartile Range)
Unit of measure:  Mg/g
Number Analyzed 28 participants 16 participants 44 participants
1282
(143 to 1848)
5
(2.5 to 8.8)
87
(0 to 6469)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  G/dl
Number Analyzed 28 participants 16 participants 44 participants
11.2  (1.7) 14.4  (1.7) 12.5  (2.3)
Hematocrit  
Mean (Standard Deviation)
Unit of measure:  Percent of red blood cells in blood
Number Analyzed 28 participants 16 participants 44 participants
33.9  (5.1) 42.6  (4.2) 36.9  (6.4)
Platelet count  
Mean (Standard Deviation)
Unit of measure:  K per microL
Number Analyzed 28 participants 16 participants 44 participants
232  (55) 217  (55) 227  (54.7)
Glycosylated hemoglobin  
Mean (Standard Deviation)
Unit of measure:  Percent of glycated hemoglobin in blood
Number Analyzed 28 participants 16 participants 44 participants
6.8  (0.4) 6.4  (0.4) 6.4  (1.3)
1.Primary Outcome
Title Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid
Hide Description 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
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Kidney Disease Normal Controls
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 16
Median (Inter-Quartile Range)
Unit of Measure: ohms
Baseline
21.0
(10.5 to 24.5)
18.0
(10.0 to 20.0)
visit 2
0
(0 to 0)
0
(0 to 0)
2.Secondary Outcome
Title Whole Blood Platelet Aggregation to 2 µg/mL Collagen
Hide Description Citrated 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
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Kidney Disease Normal Controls
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 16
Median (Inter-Quartile Range)
Unit of Measure: ohms
Baseline
28.5
(23.5 to 31.5)
25.0
(20.0 to 30.0)
visit 2
19.5
(16.0 to 26.0)
19.0
(16.0 to 22.0)
3.Secondary Outcome
Title Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate
Hide Description Citrated 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
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Kidney Disease Normal Controls
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 16
Mean (Inter-Quartile Range)
Unit of Measure: ohms
Baseline
13.5
(9.5 to 16.0)
9.0
(6.0 to 12.0)
visit 2
11.0
(8.0 to 16.0)
10.0
(8.0 to 11.0)
visit 3
8.0
(1.0 to 12.0)
3.0
(0 to 4.0)
Time Frame Adverse events were collected throughout the period of the study visits for an average of 4 weeks.
Adverse Event Reporting Description not different
 
Arm/Group Title Chronic Kidney Disease Normal Controls
Hide Arm/Group Description

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

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

All-Cause Mortality
Chronic Kidney Disease Normal Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Chronic Kidney Disease Normal Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chronic Kidney Disease Normal Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/28 (17.86%)      9/16 (56.25%)    
Blood and lymphatic system disorders     
Brusing or nose bleed   5/28 (17.86%)  5 9/16 (56.25%)  9
Indicates events were collected by systematic assessment
Limited by residual confounding due to small sample size and lack of randomization ex vivo measurement of platelet function which may be different from in vivo function Sub-optimal reproducibility of platelet assays
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nishank Jain, MD
Organization: University of Arkansas for Medical Sciences
Phone: 5016865295
EMail: njain2@uams.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01768637     History of Changes
Other Study ID Numbers: 12CRP11830004
First Submitted: January 10, 2013
First Posted: January 15, 2013
Results First Submitted: March 28, 2018
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019