NCT02219412

Brief Summary

This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirin/ticagrelor dual-therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
10 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

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

July 24, 2014

Last Update Submit

June 20, 2016

Conditions

Coronary Heart Disease

Keywords

ticagrelorplatelet aggregation rateADP antagonistantiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • The rate of AA induced platelet aggregation

    The rate of AA induced platelet aggregation will be measured at day 14 after randomization.

    Day 14 after randomization

Secondary Outcomes (4)

  • The rate of ADP induced platelet aggregation

    Day 7 and day 14 after randomization

  • The rate of collagen induced platelet aggregation

    Day 7 and day 14 after randomization

  • The serum concentration of Thromboxane B2

    Day 7 and day 14 after randomization

  • The rate of AA induced platelet aggregation

    Day 7 after randomization

Study Arms (2)

ticagrelor mono-therapy

EXPERIMENTAL

Take ticagrelor 90 mg Bid for 2 weeks.

Drug: ticagrelor

aspirin/ticagrelor dual-therapy

ACTIVE COMPARATOR

Take ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks.

Drug: ticagrelorDrug: Aspirin

Interventions

ticagrelorDRUG

90 mg bid for 2 weeks

Also known as: Brilinta
aspirin/ticagrelor dual-therapyticagrelor mono-therapy
AspirinDRUG

100mg Qd for 2 weeks.

aspirin/ticagrelor dual-therapy

Eligibility Criteria

Age18 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.
  • Aged \>18 years.
  • Documented stable coronary artery disease.
  • Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.

You may not qualify if:

  • History of acute coronary syndrome within 12 months of screening.
  • History of percutaneous coronary intervention within 12 months of screening.
  • Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).
  • AA induced platelet aggregation rate \>20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.
  • Congestive heart failure or left ventricular ejection fraction \<35%.
  • Forced expiratory volume in the first second forced vital capacity below the lower limits of normal.
  • Bleeding diathesis or severe pulmonary disease.
  • Active pathological bleeding.
  • History of intracranial hemorrhage.
  • Hypersensitivity to ticagrelor or any of the excipients.
  • Severe hepatic impairment.
  • Pregnancy.
  • Current smoking.
  • Platelet count \<100 000/mm3 or hemoglobin \<10 g/dL.
  • HemoglobinA1c \>10%.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

TicagrelorAspirin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Huo Yong, MD

    Peking University First Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The director of the Department of Cardiology and heart center of Peking University First Hospital

Study Record Dates

First Submitted

July 24, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

June 21, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)