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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Stable Angina
 Drug: Clopidogrel, cilostazol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 85
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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 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.
 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: 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.
 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: 75mg clopidogrel
control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328470

Locations
Korea, Republic of
Kyung Hee University
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Weon Kim, MD, PhD Kyung Hee University
  More Information

Additional Information:
Kyung Hee University Institutional Ethics Committee  This link exits the ClinicalTrials.gov site
Korea Food and Drug Administration  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kyunghee University
ClinicalTrials.gov Identifier: NCT01328470     History of Changes
Other Study ID Numbers: PIANO-CKD2
Study First Received: March 30, 2011
Last Updated: April 1, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
platelet
cilostazol
clopidogrel
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Cilostazol
Ticlopidine
Clopidogrel
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
 Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013