NCT02319941

Brief Summary

The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

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

First Submitted

Initial submission to the registry

December 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

May 20, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

December 15, 2014

Last Update Submit

June 15, 2017

Conditions

Acute Coronary Syndrome

Keywords

Inhibition of Platelet ReactivityticagrelorclopidogrelPharmacodynamicsPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • P2Y12 reaction units(PRU)

    P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay

    8 hours and 30days after first randomized dose

Secondary Outcomes (7)

  • Percentage inhibition of platelet aggregation

    0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment

  • Aggregation units(AU), Area Under the Curve(AUC)

    0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment

  • Percentage of low-responsive patients

    0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment

  • Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX

    0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment

  • MACE(Major adverse cardiac event)

    30 days after first randomized study treatment

  • +2 more secondary outcomes

Study Arms (3)

Low dose ticagrelor

EXPERIMENTAL

60mg bid

Drug: ticagrelor

standard dose ticagrelor

ACTIVE COMPARATOR

90mg bid

Drug: ticagrelor

standard dose clopidogrel

ACTIVE COMPARATOR

75mg qd

Drug: clopidogrel

Interventions

ticagrelorDRUG
Low dose ticagrelorstandard dose ticagrelor
clopidogrelDRUG
standard dose clopidogrel

Eligibility Criteria

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

You may qualify if:

  • ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours

You may not qualify if:

  • Known hypersensitivity to clopidogrel and ticagrelor and aspirin
  • Treatment with anticoagulants
  • Exposure to a thrombolytic agent within 24 hours prior to randomization
  • Use of glycoprotein IIb - IIIa inhibitors at randomization
  • History of major hemorrhage (intracranial, gastrointestinal, etc.)
  • clotting disorder and/or bleeding disorder
  • Any history of Severe renal or hepatic dysfunction
  • Hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 80,000 cells/mm3
  • Cardiac shock, severe left ventricular dysfunction LVEF less than 30%
  • Sick sinus syndrome or second degree of av block without permanent pacemaker
  • No concurrent cytochrome p450 3a inhibitors and enhancers within 2 weeks
  • Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg,drug and alcohol abuse, mental illness) or that could prevent, limit, or confound the protocol-specified assessments.
  • Life expectancy of less than 6 months
  • Pregnancy or lactating
  • Participation in any drug study in the previous 3 months
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Related Publications (1)

  • Park DW, Lee PH, Jang S, Lim HS, Kang DY, Lee CH, Ahn JM, Yun SC, Park SW, Park SJ. Effect of Low-Dose Versus Standard-Dose Ticagrelor and Clopidogrel on Platelet Inhibition in Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Apr 10;71(14):1594-1595. doi: 10.1016/j.jacc.2018.02.010. No abstract available.

    PMID: 29622168DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 18, 2014

Study Start

May 20, 2015

Primary Completion

February 14, 2017

Study Completion

March 10, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

KR(1)