Recruiting

Ticagrelor & Aspirin

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT03005704

Conditions

Ticagrelor

Aspirin

Platelet Dysfunction Due to Drugs

Transfusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Antiplatelet treatment

Study Details

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.

Conditions

Ticagrelor

Aspirin

Platelet Dysfunction Due to Drugs

Transfusion

Study ID

NCT03005704

Start date

Jan, 2017

Status verified date

Apr, 2017

Completion date

Jan, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Antiplatelet Treatment

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

no intervention: Control

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

Interventions

Antiplatelet treatment

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.

Primary outcome measure

  • Reversal of platelet inhibition [ Time Frame: 5 days ]

Central Contacts and Locations

Locations

Population Health Research Institute

Recruiting

Hamilton, Ontario, Canada, L9L 2X2

Contacts

Paul Kruger, MB BS

9059230285paul.kruger@phri.ca

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 6, 2017

Last verified

Apr, 2017

Keywords

  • Ticagrelor
  • Acetylsalicylic acid
  • Platelet transfusion
  • Reversal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2017-04-06.