Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Aspirin; Clopidogrel
Intervention description: Aspirin 81 mg by mouth daily; Clopidogrel 75 mg by mouth once daily
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 21 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic kidney disease; Platelet function; aspirin; antiplatelet agent

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 <30

        Controls:

        estimated glomerular filtration rate of >90, urinary albumin to creatinine ratio <30 and no
        other kidney damage

        Exclusion Criteria:

          -  End-stage renal disease (peritoneal dialysis and hemodialysis)

          -  Kidney transplant or any other transplant patient

          -  Recent hospitalizations <3 months

          -  Acute coronary or cerebrovascular event in the last 12 months

          -  Surgery in the last 3 months

          -  Blood dyscrasias or active bleeding

          -  Gastro-intestinal bleeding in the last 6 months

          -  Concomitant use of other anti-platelet agent or antithrombotic drugs

          -  Recent treatment (<30 days) with a glycoprotein antagonist or proton pump inhibitor

          -  Hematocrit <25% or white blood cell count >20,000 or platelet count <50,000

          -  Any active malignancy or liver disease

          -  No current diagnosis of depression, not on any antidepressant medications,