Last updated: December 8, 2022
Sponsor: University of Arkansas
Overall Status: Completed
Phase
3
Condition
Coronary Artery Disease
Circulation Disorders
Thrombosis
Treatment
N/AClinical Study ID
NCT03649711
227997
1241997
Ages 18-91 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females, aged 18-91 years
- Ability to understand and sign informed consent after the nature of the study has beenfully 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 KidneyFoundation (NKF) and determined with the CKD-EPI creatinine-based formula
- Controls with normal kidney function: participants with an estimated GFR >90mL/min/1.73 m2 as determined by the CKD-EPI creatinine-based formula and a urinealbumin-to-creatinine ratio <30 mg/g as defined by the National Kidney Foundation
Exclusion
Exclusion Criteria:
- No healthcare power of attorney to sign informed consent
- Unwillingness or inability to participate in the protocol or comply with any of itscomponents.
- 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 studyentry. A female of childbearing potential is any woman (regardless of sexualorientation, having undergone a tubal ligation, or remaining celibate by choice) whomeets 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 thepotential of this regimen to harm nursing infants.
Study Design
Total Participants: 76
Study Start date:
November 01, 2018
Estimated Completion Date:
September 02, 2021
Study Description
Connect with a study center
Central Arkansas Veterans Affairs Hospital
Little Rock, Arkansas 72205
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
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