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Trial record 70 of 1300 for:    ASPIRIN AND Platelet Aggregation

Chronic Kidney Disease (CKD) Platelet Study

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ClinicalTrials.gov Identifier: NCT03649711
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
American Society of Nephrology
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Heart Attack Stroke, Ischemic Drug: Ticagrelor 90mg Drug: Clopidogrel 75mg Drug: Aspirin 81 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study)
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: Brilinta

Drug: Aspirin 81 mg
Aspirin Pill
Other Name: 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: Clopidogrel 75mg
Clopidogrel Pill and a matching placebo to conceal frequency
Other Name: Plavix

Drug: Aspirin 81 mg
Aspirin Pill
Other Name: baby aspirin

Active Comparator: Control-ticagrelor
Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d
Drug: Ticagrelor 90mg
Ticagrelor Pill
Other Name: Brilinta

Drug: Aspirin 81 mg
Aspirin Pill
Other Name: baby aspirin




Primary Outcome Measures :
  1. ADP induced platelet aggregation [ Time Frame: 2 weeks ]
    measured in ohms


Secondary Outcome Measures :
  1. Platelet surface P-selectin expression [ Time Frame: 2 weeks ]
    measured using flow cytometry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649711


Contacts
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Contact: Jain Nishank, MD 501-686-5295 NJain2@uams.edu
Contact: Giuseppina Dusio, Ph D 501-686-5301 gdusio@uams.edu

Locations
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United States, Arkansas
Central Arkansas Veterans Affairs Hospital Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Luis Juncos, MD    501-257-1000 ext 5877    luis.juncos@va.gov   
Contact: Brandi Mojica, BA    5012571000 ext 5877    brandi.mojica@va.gov   
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jain Nishank, MD    501-686-5295    NJain2@uams.edu   
Contact: Giuseppina Dusio, Ph D    501-6865301    gdusio@uams.edu   
Sponsors and Collaborators
University of Arkansas
American Society of Nephrology
Investigators
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Principal Investigator: Jain Nishank, MD University of Arkansas for Medical

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03649711     History of Changes
Other Study ID Numbers: 227997
1241997 ( Other Identifier: Central Arkansas Veterans Affairs Hospital )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data for all primary and secondary outcome measures will be uploaded on clinicaltrials.gov website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 2 years after study closure indefinitely

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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
Keywords provided by University of Arkansas:
P2Y12 inhibitors
Platelet aggregation
ticagrelor
clopidogrel
chronic kidney disease
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Kidney Diseases
Renal Insufficiency, Chronic
Myocardial Infarction
Urologic Diseases
Renal Insufficiency
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists