CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Aspirin +1 moredrug
Likely dose
Aspirin 81 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01768637
NCT01768637Phase 1Completed

Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin

University of Texas Southwestern Medical Center·interventional·Posted Jan 15, 2013·Updated Apr 19, 2019

In Brief

A Phase 1 clinical trial evaluating Aspirin and Clopidogrel for Chronic Kidney Disease. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.5 years ago

Interventions

Aspirindrug

Aspirin 81 mg by mouth daily

Clopidogreldrug

Clopidogrel 75 mg by mouth once daily