search
Back to results

Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease (CKD)

Primary Purpose

Chronic Kidney Disease, Stable Angina

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clopidogrel, cilostazol
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring platelet, cilostazol, clopidogrel, chronic kidney disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Kyung Hee University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

clopidogrel 75 mg/day

clopidogrel 150 mg/day

adjunctive cilostazol

75mg clopidogrel

Arm Description

CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.

CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.

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.

control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 30, 2011
Last Updated
April 1, 2011
Sponsor
Kyunghee University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01328470
Brief Title
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
Acronym
CKD
Official Title
Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Stable Angina
Keywords
platelet, cilostazol, clopidogrel, chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clopidogrel 75 mg/day
Arm Type
Active Comparator
Arm Description
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.
Arm Title
clopidogrel 150 mg/day
Arm Type
Active Comparator
Arm Description
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.
Arm Title
adjunctive cilostazol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
75mg clopidogrel
Arm Type
Active Comparator
Arm Description
control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
Intervention Type
Drug
Intervention Name(s)
Clopidogrel, cilostazol
Other Intervention Name(s)
Plavix, pletaal
Intervention Description
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
Primary Outcome Measure Information:
Title
The differences of platelet aggregation according to the anti-platelet therapy.
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Changes of platelet activation markers according to the anti-platelet therapy
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19840579
Citation
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.
Results Reference
result
PubMed Identifier
17261652
Citation
Angiolillo 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 Reference
result
PubMed Identifier
20223369
Citation
Angiolillo 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.
Results Reference
result
PubMed Identifier
35224730
Citation
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.
Results Reference
derived
PubMed Identifier
22137075
Citation
Woo 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.
Results Reference
derived
Links:
URL
http://www.kfda.go.kr
Description
Korea Food and Drug Administration

Learn more about this trial

Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease

We'll reach out to this number within 24 hrs