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Completed

NCT Number: NCT03649711

Chronic Kidney Disease (CKD) Platelet Study

This study evaluates how aspirin, clopidogrel and ticagrelor work in people with chronic kidney disease (CKD) compared to people with normal kidneys. In the first part of the study, half of CKD participants will be randomly assigned to ticagrelor and aspirin, while the other half will be assigned to clopidogrel and aspirin in a blinded fashion. The treatment duration will be two weeks. After recruiting CKD participants the investigator will recruit controls with normal kidney function that will receive only ticagrelor and aspirin for two weeks.

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Key information

About this study

It is known that people with chronic kidney disease (CKD) are at higher risk to have heart and blood vessel problems like heart attack and stroke compared to people that do not have kidney problems. Aspirin, clopidogrel and ticagrelor prevent blood clots building up in the vessels. If a blood clot is present in one vessel, it could stop oxygen carrying blood to get to a specific organ, and that could cause problems like heart attack or stroke. There is very little knowledge about the way this group of medicines works in people with chronic kidney disease as well as it works in individuals with normal kidney function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females, aged 18-91 years
  • Ability to understand and sign informed consent after the nature of the study has been fully explained
  • CKD participants: Non-dialysis CKD patients: Presence of CKD with an estimated GFR of <30 mL/min/1.73 m2 for a period of ≥3 months, as defined by the National Kidney Foundation (NKF) and determined with the CKD-EPI creatinine-based formula
  • Controls with normal kidney function: participants with an estimated GFR >90 mL/min/1.73 m2 as determined by the CKD-EPI creatinine-based formula and a urine albumin-to-creatinine ratio <30 mg/g as defined by the National Kidney Foundation

Exclusion criteria

  • No healthcare power of attorney to sign informed consent
  • Unwillingness or inability to participate in the protocol or comply with any of its components.
  • Subjects unable or unwilling to stop taking:
  • Aspirin and other antithrombotic agents, like cilostazol, ranolazine, aggrenox, prasugrel, warfarin, xarelto, pradaxa, eliquis.
  • Glycoprotein IIb/IIIa antagonist (abciximab-ReoPro, eptifibatide-Integrilin, tirofiban-Aggrastal)
  • NSAIDs and PPIs
  • Fish oil, Vitamin E and herbal supplements
  • Acute kidney injury superimposed on CKD
  • Kidney transplant or any other solid organ transplant recipient
  • End-stage kidney disease on maintenance dialysis (peritoneal or hemodialysis)
  • Nephrotic syndrome defined as nephrotic range proteinuria, hypoalbuminemia, hyperlipidemia and generalized edema
  • Recent hospitalization or surgery <3 months
  • Acute coronary or cerebrovascular event in the last 12 months
  • Blood dyscrasias, active bleeding, or bleeding diathesis
  • Gastrointestinal bleeding in the last 6 months
  • Recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist (Integrelin).
  • Hematocrit <25%, white blood cell count >20,000/μL, or platelet count <50,000/μL
  • Any active malignancy or liver disease.
  • Pregnancy
  • Positive urine pregnancy test in a woman of childbearing potential prior to study entry. A female of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Patients must not be nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Treatment and study plan

Ticagrelor 90mg

Drug

Ticagrelor Pill

Other names: Brilinta

Clopidogrel 75mg

Drug

Clopidogrel Pill and a matching placebo to conceal frequency

Other names: Plavix

Aspirin 81 mg

Drug

Aspirin Pill

Other names: baby aspirin

Primary outcomes

  1. ADP Induced Platelet Aggregation

    Time frame: 2 weeks

    We will use summary statistics to describe the distribution of the data. Post-treatment ADP-induced WBPA value in ohms (Ω) will be the primary outcome variable. We will use an analysis of covariance (ANCOVA) model to compare the treatment effects of ticagrelor vs. clopidogrel in CKD patients because this approach has higher statistical power than other methods to analyze drug effects. T

Secondary outcomes

  1. Platelet Surface P-selectin Expression

    Time frame: 2 weeks

    Platelet surface P-selectin expression was measured using flow cytometry before and after treatment.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • American Society of Nephrology

Registry information

Official study title

A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study)

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2018
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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