NCT02163954

Brief Summary

Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 12, 2014

Last Update Submit

June 12, 2014

Conditions

Chronic Kidney Disease

Keywords

plateletticagrelorclopidogrelend stage renal diseasehemodialysis

Outcome Measures

Primary Outcomes (1)

  • The difference of antiplatelet effects assessed by VerifyNow assay

    The difference of PRU values achieved following antiplatelet therapy

    14 days after study drug treatment

Secondary Outcomes (1)

  • the rate of onset and offset of the antiplatelet effects

    14 days after study drugs treatment

Other Outcomes (1)

  • Adverse events

    during study period

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Patients treated with clopidogrel for 14 days

Drug: TicagrelorDrug: Clopidogrel

Ticagrelor

EXPERIMENTAL

Patients treated with ticagrelor for 14 days

Drug: TicagrelorDrug: Clopidogrel

Interventions

TicagrelorDRUG

After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.

Also known as: Ticagrelor (Brilinta)
ClopidogrelTicagrelor
ClopidogrelDRUG

After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.

Also known as: Clopidogrel (Plavix)
ClopidogrelTicagrelor

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD patients undergoing regular (≥ 6 months) maintenance HD
  • ongoing (≥ 2 months) treatment with clopidogrel
  • P2Y12 reaction units (PRUs) were more than 235

You may not qualify if:

  • known allergies to aspirin, clopidogrel, or ticagrelor
  • concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
  • thrombocytopenia (platelet count \<100,000/mm3)
  • hematocrit \<25%
  • uncontrolled hyperglycemia (hemoglobin A1c \>10%)
  • liver disease (bilirubin level \>2 mg/dl)
  • symptomatic severe pulmonary disease
  • active bleeding or bleeding diathesis
  • gastrointestinal bleeding within the last 6 months
  • hemodynamic instability
  • acute coronary or cerebrovascular event within the last 3 months
  • pregnancy
  • any malignancy
  • concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
  • recent treatment (\<30 days) with a glycoprotein IIb/IIIa antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, 130-702, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35224730DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Weon Kim, MD, PhD

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

KR(1)