NCT02406911

Brief Summary

Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD) is still challenging because of bleeding and thrombotic complications. The investigators hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared with ticagrelor twice a day dose in ESRD patients on HD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

March 14, 2015

Last Update Submit

March 30, 2015

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 (3)

  • The difference of antiplatelet effects assessed by light aggregometry assay

    14 days after study drug treatment

  • The difference of endothelial function assessed by forearm flow-mediated vasodilation (FMD) and peripheral arterial tonometry (PAT)

    14 days after study drug treatment

  • The difference of anti-inflammatory biomarkers

    14 days after study drug treatment

Other Outcomes (1)

  • Adverse events

    6 weeks

Study Arms (2)

Ticagrelor 90 mg

EXPERIMENTAL

After randomization, an initial loading dose of ticagrelor (180 mg) was given and low dose ticagrelor (ticagrelor 90 mg once a day) was treated for 14 days.

Drug: Ticagrelor

Ticagrelor 180 mg

ACTIVE COMPARATOR

After randomization, an initial loading dose of ticagrelor (180 mg) was given and usual dose ticagrelor (ticagrelor 90 mg twice a day) was treated for 14 days.

Drug: Ticagrelor

Interventions

TicagrelorDRUG

After randomization, each group will be treated as assigned dose of ticagrelor (ticagrelor 90mg once a day or 90mg twice a day) for 14 days. After 1 week wash-out period, cross-over study will be performed

Also known as: Ticagrelor (Brilinta)
Ticagrelor 180 mgTicagrelor 90 mg

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, Seoul, 130-872, South Korea

RECRUITING

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

Ticagrelor

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 NucleosidesRibonucleosides

Study Officials

  • Weon kim, MD, PhD

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weon Kim, MD, PhD

CONTACT

82-2-958-8170mylovekw@hanmail.net

Jong Shin Woo, MD, PhD

CONTACT

82-2-958-8176snowball77@hanmail.net

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

March 14, 2015

First Posted

April 2, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

KR(1)