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

Tracking Information

First Received Date ^ICMJE

March 30, 2011

Last Updated Date

April 1, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01328470 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Kidney Disease
Stable Angina

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01328470

Other Study ID Numbers ^ICMJE

PIANO-CKD2

Has Data Monitoring Committee

Yes

Responsible Party

Kyunghee University

Study Sponsor ^ICMJE

Kyunghee University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Weon Kim, MD, PhD

Kyung Hee University

Information Provided By

Kyunghee University Medical Center

Verification Date

July 2009

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

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