Chronic Kidney DiseasesPhase 3NCT03649711
Chronic Kidney Disease (CKD) Platelet Study
A Phase 3 study testing Ticagrelor 90mg, Clopidogrel 75mg and Aspirin 81 mg in people with Chronic Kidney Diseases and Heart Attack, run by University of Arkansas at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 91 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Heart Attack, Stroke, Ischemic
- What is being tested?
- Ticagrelor 90mg, Clopidogrel 75mg and Aspirin 81 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2018to 2 Sep 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 91 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Arkansas Veterans Affairs Hospital
Little Rock, Arkansas, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Heart Attack, Stroke, Ischemic
- Being tested
- Ticagrelor 90mg, Clopidogrel 75mg, Aspirin 81 mg
- Keywords
- P2Y12 inhibitors, Platelet aggregation, ticagrelor, clopidogrel, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Myocardial Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mgDrug
Also called Brilinta
Ticagrelor Pill
Clopidogrel 75mgDrug
Also called Plavix
Clopidogrel Pill and a matching placebo to conceal frequency
Aspirin 81 mgDrug
Also called baby aspirin
Aspirin Pill
| Study group | Role | What they receive |
|---|---|---|
| CKD-Ticagrelor | Experimental | Ticagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81 mg/d Receives: Drug: Ticagrelor 90mg; Drug: Aspirin 81 mg |
| CKD-Clopidogrel | Active comparator | 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 Receives: Drug: Clopidogrel 75mg; Drug: Aspirin 81 mg |
| Control-ticagrelor | Active comparator | Open label ticagrelor, 90 mg twice daily + aspirin 81 mg/d Receives: Drug: Ticagrelor 90mg; Drug: Aspirin 81 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADP Induced Platelet Aggregation
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
Measured: 2 weeks
Secondary outcomes (1)
Platelet Surface P-selectin Expression
Platelet surface P-selectin expression was measured using flow cytometry before and after treatment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Nov 2018
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Nephrology
- Responsible party
- Sponsor
- Investigators
- Jain Nishank, MD, Principal investigator, University of Arkansas for Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649711
- Sponsor's protocol ID
- 227997
- Other IDs
- 1241997
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2018
- Last updated
- 29 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for all primary and secondary outcome measures will be uploaded on clinicaltrials.gov website.
Publications
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.
PubMed 36682595Natale 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.
PubMed 35224730
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study)
- ClinicalTrials.gov ID
- NCT03649711
- Acronym / sponsor ID
- 227997
- Conditions
- Chronic Kidney Diseases, Heart Attack, Stroke, Ischemic
- Keywords
- P2Y12 inhibitors, Platelet aggregation, ticagrelor, clopidogrel, chronic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- American Society of Nephrology
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 29 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| CKD-Ticagrelor | Experimental | Drug: Ticagrelor 90mg, Drug: Aspirin 81 mgTicagrelor 90 mg twice daily (double blind, random assignment) + aspirin 81 mg/d |
| CKD-Clopidogrel | Active comparator | Drug: Clopidogrel 75mg, Drug: Aspirin 81 mgClopidogrel 75 mg/day in the morning and a matching placebo in the evening to conceal frequency (double blind, random assignment) + aspirin 81 mg/d |
| Control-ticagrelor | Active comparator | Drug: Ticagrelor 90mg, Drug: Aspirin 81 mgOpen label ticagrelor, 90 mg twice daily + aspirin 81 mg/d |
Who may qualify
- Ages
- 18 to 91 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- Acute kidney injury superimposed on CKD
- Kidney transplant or any other solid organ transplant recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor 90mgAlso: BrilintaTicagrelor Pill | Drug | CKD-Ticagrelor, Control-ticagrelor |
| Clopidogrel 75mgAlso: PlavixClopidogrel Pill and a matching placebo to conceal frequency | Drug | CKD-Clopidogrel |
| Aspirin 81 mgAlso: baby aspirinAspirin Pill | Drug | CKD-Clopidogrel, CKD-Ticagrelor, Control-ticagrelor |
Primary outcome
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
1 secondary outcome
Platelet Surface P-selectin Expression
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36682595Jain 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.
- Derived from this study: PubMed 35224730Natale 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.
- publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data for all primary and secondary outcome measures will be uploaded on clinicaltrials.gov website.
Related trials for Chronic Kidney Diseases
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jain Nishank, MD principal investigator
University of Arkansas for Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor 90mg, Clopidogrel 75mg and Aspirin 81 mg in people with Chronic Kidney Diseases and Heart Attack, run by University of Arkansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADP Induced Platelet Aggregation (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.