Phase 1
N=48
Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01768637 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid — 21.0; 18.0; 0; 0 ohms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Aspirin (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid |
21.0; 18.0; 0; 0 | — |
| SECONDARY Whole Blood Platelet Aggregation to 2 µg/mL Collagen |
28.5; 25.0; 19.5; 19.0 | — |
| SECONDARY Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate |
13.5; 9.0; 11.0; 10.0; 8.0; 3.0 | — |
Summary
Higher coronary in-stent thromboses and bleeding complications on anti-platelet agents are more common in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Poor inhibition of platelet aggregation by anti-platelet agents predicts future cardiovascular events. Clinical practice guidelines are ambiguous about the use of these agents in Chronic Kidney Disease due to lack of controlled studies. The investigators hypothesize that patients with Chronic Kidney Disease compared with non-Chronic Kidney Disease have reduced platelet aggregation and poor platelet inhibitory response to aspirin. The aims are to 1) define the range of whole blood platelet aggregation in stages 3-5 Chronic Kidney Disease patients; 2) investigate whether patients with stages 4-5 Chronic Kidney Disease vs. non-Chronic Kidney Disease have lower platelet aggregation or impaired von Willebrand Factor activity; and 3) compare inhibition of platelet aggregation from baseline after 2 weeks of aspirin therapy and another 2 weeks of clopidogrel therapy added to aspirin in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Accomplishing these aims will provide pilot data to power future studies of targeted anti-platelet agent treatments in Chronic Kidney Disease in order to improve cardiovascular outcomes.
Eligibility Criteria
Inclusion Criteria
- Male or female >21 years
Cases:
Chronic kidney disease stages 4-5, with estimated glomerular filtration rate of 90, urinary albumin to creatinine ratio 20,000 or platelet count <50,000
- Any active malignancy or liver disease
- No current diagnosis of depression, not on any antidepressant medications,
Data sourced from ClinicalTrials.gov (NCT01768637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.