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

This study has been completed.
Sponsor:
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01328470
First received: March 30, 2011
Last updated: April 1, 2011
Last verified: July 2009

March 30, 2011
April 1, 2011
September 2009
August 2010   (final data collection date for primary outcome measure)
The differences of platelet aggregation according to the anti-platelet therapy. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01328470 on ClinicalTrials.gov Archive Site
Changes of platelet activation markers according to the anti-platelet therapy [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Stable Angina
Drug: Clopidogrel, cilostazol
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
Other Names:
  • Plavix
  • pletaal
  • Active Comparator: clopidogrel 75 mg/day
    CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.
    Intervention: Drug: Clopidogrel, cilostazol
  • Active Comparator: clopidogrel 150 mg/day
    CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.
    Intervention: Drug: Clopidogrel, cilostazol
  • Active Comparator: adjunctive cilostazol
    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.
    Intervention: Drug: Clopidogrel, cilostazol
  • Active Comparator: 75mg clopidogrel
    control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
    Intervention: Drug: Clopidogrel, cilostazol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01328470
PIANO-CKD2
Yes
Kyunghee University
Kyunghee University Medical Center
Not Provided
Principal Investigator: Weon Kim, MD, PhD Kyung Hee University
Kyunghee University Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP