Whole Blood Platelet Aggregation in Chronic Kidney Disease on Aspirin and Clopidogrel Study

Study ID
STU 082012-089

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Dallas Veteran's Affairs Medical Center
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Kyle West
214-645-8294
kyle.west@utsouthwestern.edu

Principal Investigator
S Hedayati

Summary

Patients will be consented for the study and asked to initial on the consent form to state whether they agree for the genetic testing. after signing informed consent, complete medical history and medication list will be obtained and verified with the ePiC electronic medical record. Patients will be screened for depression to make sure that they are not depressed. after meeting all inclusion and exclusion criteria during the screening visit, those patients on aspirin for primary prevention of CV events will be asked to stop it for 2 weeks prior to blood collection for baseline data. normal controls will be chosen after frequency matching for decade of age, gender, diabetes mellitus and interval of body mass index (5 kg/m2). Dietary supplements (Vitamin e and fish oil) known to affect platelet function will be assessed and patients on those will be asked to discontinue these. Participants with also be asked to not eat foods known to affect platelet function (coffee, chocolate, grapes, and alcohol) 48 hours prior to sample collection on visit 1. an interviewer-administered assessment of diet and exercise with a modified 24-hour dietary recall and the Stanford 7-day Physical activity Recall will be performed to ensure dietary consistency which may affect platelet aggregability on visit 1. Blood will be drawn via venopuncture for laboratory studies (WBPa, platelet factor 4, beta thromboglobulin and VWF antigen levels and activity). Participants will be administered aspirin 81 mg for 2 weeks and asked to return in 2 weeks. on visit 2, WBPa will be re-measured and questionnaires filled out. Two oral swabs will be taken from those participants who consented for genetic testing and samples will be stored at uTSW for short term until shipped to Harmonyx Diagnostics inc. Laboratory for genetic testing of clopidogrel CYP polymorphisms. all participants will be administered clopidogrel 75 mg daily on top of aspirin 81 mg for 2 weeks and asked to return in 2 weeks. on visit 3, WBPa will be re-measured and questionnaires filled out. at the completion of the study, participants will be placed back on their original antiplatelet agent if applicable and referred back to the primary care provider.

Participant Eligibility

Male or female >21 years

Cases:
CKD stages 4-5, with eGFR of <30 mL/min/1.73 m2

Controls:
eGFR of >90 mL/min/1.73 m2, urinary albumin-to-creatinine ratio (ACR) <30 mg/g, and no other kidney damage