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Completed

NCT Number: NCT01328470

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

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.

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Key information

Conditions

Chronic Kidney Disease Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Stable Angina Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee University

Seoul, 130-702, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clopidogrel, cilostazol

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes of platelet activation markers according to the anti-platelet therapy

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study title

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

Acronym: CKD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 4, 2011
Registry last updated
Apr 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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