Chronic Kidney DiseasePhase 3NCT02394145
Genotype and Platelet Reactivity in Patients on Hemodialysis
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Chronic Kidney Disease, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD patients undergoing regular (≥ 6 months) maintenance HD
- Matching patients with normal kidney function
- documented coronary artery disease or high risk (Framingham heart risk score ≥ 20%) of coronary artery disease
Who cannot join
- known allergies to aspirin, clopidogrel, or ticagrelor
- concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
- thrombocytopenia (platelet count <100,000/mm3)
- hematocrit <25%
- uncontrolled hyperglycemia (hemoglobin A1c >10%)
- liver disease (bilirubin level >2 mg/dl)
Show all 15Show fewer
- symptomatic severe pulmonary disease
- active bleeding or bleeding diathesis
- gastrointestinal bleeding within the last 6 months
- hemodynamic instability
- acute coronary or cerebrovascular event within the last 3 months
- pregnancy
- any malignancy
- concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
- recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, Seoul, 130-872
Weon Kim, MD, PhD, 2-958-8170 ext. 82, mylovekw@hanmail.net
Jong Shin Woo, MD, 2-958-8176 ext. 82, snowball77@hanmail.net
About this study
Official title: The Relationship Between Genotype and Platelet Reactivity in Patients Treated With Ticagrelor Versus Clopidogrel: PIANO Genotype Study
Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted genetic influence in high platelet reactivity in patients with ESRD on HD.
Read the detailed description
Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was markedly greater than by clopidogrel in patients with ESRD on HD. But exact mechanism of high platelet reactivity in ESRD patients was not fully evaluated. A possible postulation would be genetic influence. To investigate this issue, we will evaluate genetic polymorphism in patients with normal kidney function and ESRD on HD according to different doses of clopidogrel and ticagrelor. Genetic test will be assessed polymorphism of ABCB1, PON1, CYP2C19, CYP2C9 and P2Y12.
- Conditions
- Chronic Kidney Disease
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- platelet, ticagrelor, clopidogrel, end stage renal disease, hemodialysis, genetics
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
Patients with normal kidney function and ESRD on hemodialysis will be treated by ticagrelor 90mg twice a day for 14 days. After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
ClopidogrelDrug
Also called Plavix
Patients with normal kidney function and ESRD on hemodialysis will be treated by clopidogrel 75mg or 150mg once a day for 14 days. After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor 180mg in ESRD patients | Experimental | After randomization, ESRD patients on HD will be treated by an initial loading dose of ticagrelor (180 mg) and maintenance doses (ticagrelor 90 mg twice daily) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. Receives: Drug: Ticagrelor |
| Clopidogrel 75mg in ESRD patients | Active comparator | After randomization, ESRD patients on HD will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 75 mg once a day) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. Receives: Drug: Clopidogrel |
| Clopidogrel 150mg in ESRD patients | Active comparator | After randomization, ESRD patients on HD will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 150 mg once a day) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. Receives: Drug: Clopidogrel |
| Ticagrelor 180mg in normal kidney | Active comparator | After randomization, patients with normal kidney function will be treated by an initial loading dose of ticagrelor (180 mg) and maintenance doses (ticagrelor 90 mg twice daily) for 14 days. Platelet reactivity and genetic polymorphism will be assessed Receives: Drug: Ticagrelor |
| Clopidogrel 75mg in normal kidney | Active comparator | After randomization, patients with normal kidney function will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 75 mg once a day) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of antiplatelet effects according to genotype
The difference of P2Y12 reaction units (PRUs) according to genotype
Measured: 14 days after study drug treatment
Secondary outcomes (1)
The difference of antiplatelet effects according to kidney function
The difference of P2Y12 reaction units (PRUs) according to kidney function
Measured: 14 days after study drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startSep 2009
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weon Kim, Kyunghee University Medical Center
- Investigators
- Weon Kim, MD, PhD, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394145
- Sponsor's protocol ID
- PIANO-genetics
- Status last verified
- Mar 2015
- First submitted
- 14 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35224730
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Genotype and Platelet Reactivity in Patients Treated With Ticagrelor Versus Clopidogrel: PIANO Genotype Study
- ClinicalTrials.gov ID
- NCT02394145
- Acronym / sponsor ID
- PIANO-genetics
- Conditions
- Chronic Kidney Disease
- Keywords
- platelet, ticagrelor, clopidogrel, end stage renal disease, hemodialysis, genetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted genetic influence in high platelet reactivity in patients with ESRD on HD.
Detailed description
Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was markedly greater than by clopidogrel in patients with ESRD on HD. But exact mechanism of high platelet reactivity in ESRD patients was not fully evaluated. A possible postulation would be genetic influence. To investigate this issue, we will evaluate genetic polymorphism in patients with normal kidney function and ESRD on HD according to different doses of clopidogrel and ticagrelor. Genetic test will be assessed polymorphism of ABCB1, PON1, CYP2C19, CYP2C9 and P2Y12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor 180mg in ESRD patients | Experimental | Drug: TicagrelorAfter randomization, ESRD patients on HD will be treated by an initial loading dose of ticagrelor (180 mg) and maintenance doses (ticagrelor 90 mg twice daily) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. |
| Clopidogrel 75mg in ESRD patients | Active comparator | Drug: ClopidogrelAfter randomization, ESRD patients on HD will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 75 mg once a day) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. |
| Clopidogrel 150mg in ESRD patients | Active comparator | Drug: ClopidogrelAfter randomization, ESRD patients on HD will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 150 mg once a day) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. |
| Ticagrelor 180mg in normal kidney | Active comparator | Drug: TicagrelorAfter randomization, patients with normal kidney function will be treated by an initial loading dose of ticagrelor (180 mg) and maintenance doses (ticagrelor 90 mg twice daily) for 14 days. Platelet reactivity and genetic polymorphism will be assessed |
| Clopidogrel 75mg in normal kidney | Active comparator | Drug: ClopidogrelAfter randomization, patients with normal kidney function will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 75 mg once a day) for 14 days. Platelet reactivity and genetic polymorphism will be assessed. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ESRD patients undergoing regular (≥ 6 months) maintenance HD
- Matching patients with normal kidney function
- documented coronary artery disease or high risk (Framingham heart risk score ≥ 20%) of coronary artery disease
Key exclusion criteria (15 listed)
- known allergies to aspirin, clopidogrel, or ticagrelor
- concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
- thrombocytopenia (platelet count <100,000/mm3)
- hematocrit <25%
- uncontrolled hyperglycemia (hemoglobin A1c >10%)
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 |
|---|---|---|
| TicagrelorAlso: BrilintaPatients with normal kidney function and ESRD on hemodialysis will be treated by ticagrelor 90mg twice a day for 14 days. After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay. | Drug | Ticagrelor 180mg in ESRD patients, Ticagrelor 180mg in normal kidney |
| ClopidogrelAlso: PlavixPatients with normal kidney function and ESRD on hemodialysis will be treated by clopidogrel 75mg or 150mg once a day for 14 days. After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay. | Drug | Clopidogrel 150mg in ESRD patients, Clopidogrel 75mg in ESRD patients, Clopidogrel 75mg in normal kidney |
Primary outcome
The difference of antiplatelet effects according to genotype
Time frame: 14 days after study drug treatment
The difference of P2Y12 reaction units (PRUs) according to genotype
1 secondary outcome
The difference of antiplatelet effects according to kidney function
Time frame: 14 days after study drug treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- 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.
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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.
Weon Kim, MD, PhD principal investigator
Kyung Hee University Hospital
1 site 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 and Clopidogrel in people with Chronic Kidney Disease, run by Kyunghee University Medical Center at 1 site in South Korea.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weon Kim, MD, PhD (82-2-958-8170, mylovekw@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of antiplatelet effects according to genotype (time frame: 14 days after study drug treatment). 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 NCT02394145, which also lists 1 linked publication.
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 20 Mar 2015.