Chronic Kidney Disease (CKD) Platelet Study

December 8, 2022 updated by: University of Arkansas

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Affairs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females, aged 18-91 years
  2. Ability to understand and sign informed consent after the nature of the study has been fully explained
  3. 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
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD-Ticagrelor
Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81 mg/d
Drug: Ticagrelor 90mg
Ticagrelor Pill
Other Names:
  • Brilinta
Drug: Aspirin 81 mg
Aspirin Pill
Other Names:
  • baby aspirin
Active Comparator: CKD-Clopidogrel
Clopidogrel 75 mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d
Drug: Aspirin 81 mg
Aspirin Pill
Other Names:
  • baby aspirin
Drug: Clopidogrel 75mg
Clopidogrel Pill and a matching placebo to conceal frequency
Other Names:
  • Plavix
Active Comparator: Control-ticagrelor
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d
Drug: Ticagrelor 90mg
Ticagrelor Pill
Other Names:
  • Brilinta
Drug: Aspirin 81 mg
Aspirin Pill
Other Names:
  • baby aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Surface P-selectin Expression
Time Frame: 2 weeks
Platelet surface P-selectin expression was measured using flow cytometry before and after treatment.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

American Society of Nephrology

Investigators

  • Principal Investigator: Jain Nishank, MD, University of Arkansas for Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

September 2, 2021

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 227997
  • 1241997 (Other Identifier: Central Arkansas Veterans Affairs Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified data for all primary and secondary outcome measures will be uploaded on clinicaltrials.gov website.

IPD Sharing Time Frame

2 years after study closure indefinitely

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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