NCT02459288

Brief Summary

A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition and safety observation.

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
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

September 23, 2014

Last Update Submit

May 28, 2015

Conditions

Acute Coronary SyndromeChronic Kidney DiseaseEnd-Stage Renal Disease

Keywords

Acute coronary syndromeChronic kidney diseaseEnd-Stage Renal DiseaseeGFRTicagrelorClopidogrel

Outcome Measures

Primary Outcomes (1)

  • platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes

    baseline, 2 weeks and 4 weeks later (compare cross over effect)

Secondary Outcomes (1)

  • Major bleeding events

    1 year

Other Outcomes (2)

  • Myocardial infarction

    1 year

  • emergent condition with hospitalization need

    30 days

Study Arms (2)

Clopidogrel first

EXPERIMENTAL

Clopidogrel (Plavix) 75 mg qd, 2 weeks; followed with Ticagrelor (Brilinta) 90 mg bd, 2 weeks

Drug: Clopidogrel first

Ticagrelor first

EXPERIMENTAL

Ticagrelor (Brilinta) 90 mg bd, 2 weeks; followed with Clopidogrel (Plavix) 75 mg qd, 2 weeks

Drug: Ticagrelor first

Interventions

Clopidogrel firstDRUG

After randomization, 2 weeks Clopidogrel (Plavix) 75 mg QD will be given and then crossover with following 2 weeks Ticagrelor (Brilinta) 90 mg bd

Also known as: C-T
Clopidogrel first
Ticagrelor firstDRUG

After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD

Also known as: T-C
Ticagrelor first

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Female and male, age between 20-75 years
  • Stage 3-5 chronic kidney disease (eGFR\<60ml/min) patients or ESRD
  • Taking standard treatment dose of clopidogrel (75mg/day) for more than 1 week
  • Patients were eligible for enrollment if they were hospitalized for an acute coronary syndrome, with or without ST-segment elevation, with an onset of symptoms during the past 6 months.
  • For patients who had an acute coronary syndrome without ST-segment elevation, at least two of the following three criteria had to be met: ST-segment changes on electrocardiography, indicating ischemia; a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors (age ≥60 years; previous myocardial infarction or coronary-artery bypass grafting \[CABG\]; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease).

You may not qualify if:

  • Oral anticoagulation therapy that cannot be stopped
  • Increased risk of bradycardia
  • Concomitant use of strong CYP3A inhibitor/inducers
  • Unwilling to sign inform consent
  • Allergic or contraindicated to any study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, National Cheng Kung University Hospital

Tainan, 704, Taiwan

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

Acute Coronary SyndromeRenal Insufficiency, ChronicKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ping-Yen Liu, MD, PhD.

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping-Yen Liu, MD, PhD.

CONTACT

+88662353535larry@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

September 23, 2014

First Posted

June 2, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations

TW(1)