NCT03005704

Brief Summary

The specific objective of this study is to investigate the potential for normal platelets to reverse the inhibition of platelet aggregation in patients treated with ticagrelor in combination with aspirin.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

December 26, 2016

Last Update Submit

April 5, 2017

Conditions

TicagrelorAspirinPlatelet Dysfunction Due to DrugsTransfusion

Keywords

TicagrelorAcetylsalicylic acidPlatelet transfusionReversal

Outcome Measures

Primary Outcomes (1)

  • Reversal of platelet inhibition

    The primary outcome is to measure the efficacy of untreated platelets in reversing the platelet inhibition due to ticagrelor in combination with aspirin by ex vivo mixing studies. Increase in platelet aggregation will be measured by light transmission aggregometry after stimulation by adenosine diphosphate, arachidonic acid, and collagen.

    5 days

Secondary Outcomes (1)

  • Timing of reversal of platelet inhibition

    5 days

Study Arms (2)

Antiplatelet Treatment

EXPERIMENTAL

Subjects will be treated with five days of ticagrelor in combination with acetylsalicylic acid.

Drug: Antiplatelet treatment

Control

NO INTERVENTION

Subjects will not receive antiplatelet treatment and their PRP will be used as the source of untreated platelets in laboratory mixing studies.

Interventions

Antiplatelet treatmentDRUG

Subjects will be treated with ticagrelor in combination with acetylsalicylic acid for five days. Ticagrelor will be administered at a loading dose of 180 mg, followed by 90 mg twice daily maintenance dose. Acetylsalicylic acid will be administered at a dose of 81 mg daily.

Also known as: Ticagrelor and acetylsalicylic acid
Antiplatelet Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • At least 18 years of age
  • No history of cardiovascular disease
  • Not taking antiplatelet therapy prior to participation

You may not qualify if:

  • Known thrombocytopenia, other coagulation disorder such as von Willebrand's disease, haemophilia
  • Allergy or intolerance to ticagrelor or aspirin (if known)
  • Consumption of drugs within the preceding fourteen days that potentially can interfere with metabolism of ticagrelor through CYP3A4, CYP3A or P-glycoprotein (eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, diltiazem, amprenavir, aprepitant, erythromycin, fluconazole, verapamil, rifampicin, dexamethasone, phenytoin, carbamazepine, phenobarbital, cyclosporine, simvastatin, atorvastatin, tolbutamide, digoxin)21
  • Previous transfusion or pregnancy (because of potential alloimmunisation)
  • Pregnant or trying to conceive, or breastfeeding
  • Unable or unwilling to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Health Research Institute

Hamilton, Ontario, L9L 2X2, Canada

RECRUITING

MeSH Terms

Interventions

TicagrelorAspirin

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 26, 2016

First Posted

December 29, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

April 6, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)