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Chronic Kidney Disease (CKD) Platelet Study

NCT ID: NCT03649711

Last Updated: 2022-12-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-09-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Diseases Heart Attack Stroke, Ischemic

Keywords

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P2Y12 inhibitors Platelet aggregation ticagrelor clopidogrel chronic kidney disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

CKD participants will be double-blind randomized in these two arms:

Arm 1 - Ticagrelor, 90 mg twice daily (one pill in the morning and one pill in the evening) + Aspirin 81 mg/day. Ticagrelor is the test treatment.

Arm 2 - Clopidogrel, 75 mg/day in the morning and a matching placebo in the evening + Aspirin 81 mg/day. Clopidogrel is the reference treatment.

Arm 3: Control with normal kidney function will be recruited after matching for age and diabetes status to the Arm 1 participants. Participants will be asked to take Ticagrelor, 90 mg twice daily (one pill in the morning and one pill in the evening) and aspirin 81 mg/day. Open label treatment.

All participants are required to take the oral treatment for a total of two weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
CKD participants will be randomly assigned into one of the 2 study groups: ticagrelor (90 mg) one pill in the morning and one pill in the evening, or, clopidogrel (75 mg) one pill in the morning + placebo one pill in the evening. Placebo looks like the study drug but has no medicine in it. Neither participant nor the study personnel will know about allocation. The study drugs will look the same, except aspirin pill which will be dispensed to everyone in an open label manner.

There is no masking for control with normal kidney function. Participants will be asked to take open label ticagrelor, 90 mg twice daily (one pill in the morning and one pill in the evening) and aspirin 81 mg/day.

Study Groups

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CKD-Ticagrelor

Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81 mg/d

Group Type EXPERIMENTAL

Ticagrelor 90mg

Intervention Type DRUG

Ticagrelor Pill

Aspirin 81 mg

Intervention Type DRUG

Aspirin Pill

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

Group Type ACTIVE_COMPARATOR

Clopidogrel 75mg

Intervention Type DRUG

Clopidogrel Pill and a matching placebo to conceal frequency

Aspirin 81 mg

Intervention Type DRUG

Aspirin Pill

Control-ticagrelor

Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d

Group Type ACTIVE_COMPARATOR

Ticagrelor 90mg

Intervention Type DRUG

Ticagrelor Pill

Aspirin 81 mg

Intervention Type DRUG

Aspirin Pill

Interventions

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Ticagrelor 90mg

Ticagrelor Pill

Intervention Type DRUG

Clopidogrel 75mg

Clopidogrel Pill and a matching placebo to conceal frequency

Intervention Type DRUG

Aspirin 81 mg

Aspirin Pill

Intervention Type DRUG

Other Intervention Names

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Brilinta Plavix baby aspirin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

91 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Society of Nephrology

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jain Nishank, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas for Medical

Locations

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Central Arkansas Veterans Affairs Hospital

Little Rock, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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Jain N, Corken A, Arthur JM, Ware J, Arulprakash N, Dai J, Phadnis MA, Davis O, Rahmatallah Y, Mehta JL, Hedayati SS, Smyth S. Ticagrelor inhibits platelet aggregation and reduces inflammatory burden more than clopidogrel in patients with stages 4 or 5 chronic kidney disease. Vascul Pharmacol. 2023 Feb;148:107143. doi: 10.1016/j.vph.2023.107143. Epub 2023 Jan 20.

Reference Type DERIVED
PMID: 36682595 (View on PubMed)

Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

Reference Type DERIVED
PMID: 35224730 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://kidney360.asnjournals.org/content/early/2022/10/26/KID.0005532022

publication

Other Identifiers

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1241997

Identifier Type: OTHER

Identifier Source: secondary_id

227997

Identifier Type: -

Identifier Source: org_study_id