Chronic Kidney DiseasePhase 4CKDNCT01328470
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
A Phase 4 study testing Clopidogrel, cilostazol in people with Chronic Kidney Disease and Stable Angina, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Stable Angina
- What is being tested?
- Clopidogrel, cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Aug 2010
- Phase
- Phase 4
- 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
- CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease
Who cannot join
- known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use before enrollment
- concomitant use of other anti-thrombotic drugs (oral anticoagulants and dipyridamole)
- platelet count <100 x 106/μL
- hematocrit < 25%
- liver disease (bilirubin > 2 mg/dl)
- active bleeding or bleeding diathesis
Show all 12Show fewer
- gastrointestinal bleeding within the last 6 months
- hemodynamic instability
- acute coronary or cerebrovascular event within 3 months
- malignancy
- concomitant use of a cytochrome P450 inhibitor or a non-steroidal anti-inflammatory drug
- recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.
Read the detailed description
The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation markers are also evaluated before and after clopidogrel or cilostazol administration. The investigators will perform a prospective, randomized study to compare the degree of platelet inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily) compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.
- Conditions
- Chronic Kidney Disease, Stable Angina
- Being tested
- Clopidogrel, cilostazol
- Keywords
- platelet, cilostazol, clopidogrel, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel, cilostazolDrug
Also called Plavix, pletaal
Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel 75 mg/day | Active comparator | CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days. Receives: Drug: Clopidogrel, cilostazol |
| clopidogrel 150 mg/day | Active comparator | CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days. Receives: Drug: Clopidogrel, cilostazol |
| adjunctive cilostazol | Active comparator | CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive co-administration of adjunctive cilostazol (100 mg twice daily) and clopidogrel (75 mg/day; [group 3, 20 patients]) for 14 days. Receives: Drug: Clopidogrel, cilostazol |
| 75mg clopidogrel | Active comparator | control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days). Receives: Drug: Clopidogrel, cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of platelet aggregation according to the anti-platelet therapy.
Platelet function was assessed with light transmittance aggregometry and the VerifyNowTM P2Y12 assay.
High on-treatment platelet reactivity was defined as 5 μmol/L of ADP-induced Aggmax > 50%.
Inhibition of platelet aggregation (IPA) was defined as the percent decrease in aggregation values obtained at baseline and after treatment.
VerifyNow-P2Y12 assay results are also assessed and expressed in P2Y12 reaction units (PRUs) and the percentage of inhibition.
Measured: 14 days
Secondary outcomes (1)
Changes of platelet activation markers according to the anti-platelet therapy
Markers of platelet activation (soluble CD40 ligand [sCD40L] and soluble P-selectin [sP-selectin]) were assessed at baseline and after 14 days of anti-platelet therapy.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Weon Kim, MD, PhD, Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328470
- Sponsor's protocol ID
- PIANO-CKD2
- Acronym
- CKD
- Status last verified
- Jul 2009
- First submitted
- 30 Mar 2011
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SH, Kim W, Park CS, Kang WY, Hwang SH, Kim W. A comparison of clopidogrel responsiveness in patients with versus without chronic renal failure. Am J Cardiol. 2009 Nov 1;104(9):1292-5. doi: 10.1016/j.amjcard.2009.06.049.
PubMed 19840579Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. doi: 10.1161/CIRCULATIONAHA.106.667741. Epub 2007 Jan 29.
PubMed 17261652Angiolillo DJ, Bernardo E, Capodanno D, Vivas D, Sabate M, Ferreiro JL, Ueno M, Jimenez-Quevedo P, Alfonso F, Bass TA, Macaya C, Fernandez-Ortiz A. Impact of chronic kidney disease on platelet function profiles in diabetes mellitus patients with coronary artery disease taking dual antiplatelet therapy. J Am Coll Cardiol. 2010 Mar 16;55(11):1139-46. doi: 10.1016/j.jacc.2009.10.043.
PubMed 20223369Natale 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 35224730Woo JS, Kim W, Lee SR, Jung KH, Kim WS, Lew JH, Lee TW, Lim CK. Platelet reactivity in patients with chronic kidney disease receiving adjunctive cilostazol compared with a high-maintenance dose of clopidogrel: results of the effect of platelet inhibition according to clopidogrel dose in patients with chronic kidney disease (PIANO-2 CKD) randomized study. Am Heart J. 2011 Dec;162(6):1018-25. doi: 10.1016/j.ahj.2011.09.003. Epub 2011 Nov 8.
PubMed 22137075
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
- ClinicalTrials.gov ID
- NCT01328470
- Acronym / sponsor ID
- CKD / PIANO-CKD2
- Conditions
- Chronic Kidney Disease, Stable Angina
- Keywords
- platelet, cilostazol, clopidogrel, chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Apr 2011 (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.
Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.
Detailed description
The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation markers are also evaluated before and after clopidogrel or cilostazol administration. The investigators will perform a prospective, randomized study to compare the degree of platelet inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily) compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| clopidogrel 75 mg/day | Active comparator | Drug: Clopidogrel, cilostazolCKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days. |
| clopidogrel 150 mg/day | Active comparator | Drug: Clopidogrel, cilostazolCKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days. |
| adjunctive cilostazol | Active comparator | Drug: Clopidogrel, cilostazolCKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive co-administration of adjunctive cilostazol (100 mg twice daily) and clopidogrel (75 mg/day; [group 3, 20 patients]) for 14 days. |
| 75mg clopidogrel | Active comparator | Drug: Clopidogrel, cilostazolcontrol group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease
Key exclusion criteria (12 listed)
- known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use before enrollment
- concomitant use of other anti-thrombotic drugs (oral anticoagulants and dipyridamole)
- platelet count <100 x 106/μL
- hematocrit < 25%
- liver disease (bilirubin > 2 mg/dl)
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 |
|---|---|---|
| Clopidogrel, cilostazolAlso: Plavix, pletaalPatients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days | Drug | 75mg clopidogrel, adjunctive cilostazol, clopidogrel 150 mg/day, clopidogrel 75 mg/day |
Primary outcome
The differences of platelet aggregation according to the anti-platelet therapy.
Time frame: 14 days
Platelet function was assessed with light transmittance aggregometry and the VerifyNowTM P2Y12 assay. High on-treatment platelet reactivity was defined as 5 μmol/L of ADP-induced Aggmax > 50%. Inhibition of platelet aggregation (IPA) was defined as the percent decrease in aggregation values obtained at baseline and after treatment. VerifyNow-P2Y12 assay results are also assessed and expressed in P2Y12 reaction units (PRUs) and the percentage of inhibition.
1 secondary outcome
Changes of platelet activation markers according to the anti-platelet therapy
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
- Results publication: PubMed 19840579Park SH, Kim W, Park CS, Kang WY, Hwang SH, Kim W. A comparison of clopidogrel responsiveness in patients with versus without chronic renal failure. Am J Cardiol. 2009 Nov 1;104(9):1292-5. doi: 10.1016/j.amjcard.2009.06.049.
- Results publication: PubMed 17261652Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. doi: 10.1161/CIRCULATIONAHA.106.667741. Epub 2007 Jan 29.
- Results publication: PubMed 20223369Angiolillo DJ, Bernardo E, Capodanno D, Vivas D, Sabate M, Ferreiro JL, Ueno M, Jimenez-Quevedo P, Alfonso F, Bass TA, Macaya C, Fernandez-Ortiz A. Impact of chronic kidney disease on platelet function profiles in diabetes mellitus patients with coronary artery disease taking dual antiplatelet therapy. J Am Coll Cardiol. 2010 Mar 16;55(11):1139-46. doi: 10.1016/j.jacc.2009.10.043.
- 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.
- Derived from this study: PubMed 22137075Woo JS, Kim W, Lee SR, Jung KH, Kim WS, Lew JH, Lee TW, Lim CK. Platelet reactivity in patients with chronic kidney disease receiving adjunctive cilostazol compared with a high-maintenance dose of clopidogrel: results of the effect of platelet inhibition according to clopidogrel dose in patients with chronic kidney disease (PIANO-2 CKD) randomized study. Am Heart J. 2011 Dec;162(6):1018-25. doi: 10.1016/j.ahj.2011.09.003. Epub 2011 Nov 8.
- Korea Food and Drug AdministrationLink provided by the sponsor.
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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
Kyunghee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel, cilostazol in people with Chronic Kidney Disease and Stable Angina, 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 1 inclusion and 12 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 4 Apr 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The differences of platelet aggregation according to the anti-platelet therapy. (time frame: 14 days). 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 NCT01328470, which also lists 5 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 4 Apr 2011.