Healthy volunteers (Prophylaxis of arterial thrombosis) MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Hjertemagnyl®
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
Other descriptive name: Aspirin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
University Hospital of Aarhus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years. 2. Capable of giving informed consent. 3. For women of childbearing potential: Use of safe contraception through the entire study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Established or assumed intolerans towards acetylsalicylic acid 2. Medical history of heart, liver or kidney disease 3. Medical history of haemophilia 4. Intake of medicine that affects the platelets or the turnover of platelets (e.g. NSAID) within the last week before study enrollment. 5. Antithrombotic treatment. 6. Current or previous medical history of gastrointestinal bleeding. 7. Thrombocytopenia (<150 x 109/l). 8. Pregnancy or current wish to achieve pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the correlation between acetylsalicylic acid and salicylic acid pharmacokinetics and the platelet inhibition determined by the following parameters: Parameters for assesing acetylsalicylic acid and salicylic acid pharmacokinetics: - Maximal concentration - Areal under the concentration curve - Time above a certain concentration - Time for maximal concentration Parameters to assess the platelet inhibition: - Platelet inhibition at the time of maximal acetylsalicylic acid and salicylic acid concentrations - Maximal platelet inhibition - Areal under the effect curve - Platelet inhibition 24 hours after acetylsalicylic acid intake (through effect) - Time for maximal platelet inhibition. ;Secondary Objective: Determine if treatment with enteric coated acetylsalicylic acid (Hjertealbyl®) and non enteric coated acetylsalicylic acid (Hjertemagnyl®) result in the same degree of platelet inhibition, and determine if assessment of treatment effect must be made at different times dependent on formulation. ;Primary end point(s): - Maximal acetylsalicylic acid concentration. - Platelet inhibition at the time of maximal acetylsalicylic acid concentration. ;Timepoint(s) of evaluation of this end point: The primary end points will be evaluated after the collection of all data. No interim analyses will be performed. Blood for measurement of the primary end points will be collected at day 7 and day 8 after intake of the 7 th. dose of acetylsalicylic acid, where we will perform serial measurements of acetylsalicylic acid concentrations and platelet aggregation. As this is a randomised cross-over study, the primary endpoints will be evaluated both after intake of non enteric coated acetylsalicylic acid (Hjertemagnyl®) and enteric coated acetylsalicylic acid (Hjertealbyl®). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Maximal salicylic acid concentration. - The area under the concentrationcurves for acetylsalicylic acid and salicylic acid - Time above a certain concentration of acetylsalicylic acid and salicylic acid. - The time for maximal concentrations of acetylsalicylic acid and salicylic acid. - Platelet inhibition at the time of maximal salicylic acid concentration. - Maximal platelet inhibition - The area under the effect curve - Platelet inhibition 24 hours after acetylsalicylic acid intake (through effect) - Time for maximal platelet inhibition. - Platelet count and other platelet-, erytrocyte- and leukocytederived Sysmex® parameters (heamatological parameters) ;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated after the collection of all data. No interim analyses will be performed. Blood for measurement of the secondary endpoints will be collected at day 7 after intake of the 7 th. dose of acetylsalicylic acid, where we will perform serial measurements of acetylsalicylic acid concentrations and platelet aggregation. As this is a randomised cross-over study, the secondary endpoints will be evaluated both after intake of non enteric coated acetylsalicylic acid (Hjertemagnyl®) and enteric coated acetylsalicylic acid (Hjertealbyl®). | — |
Countries
Denmark
Contacts
Public ContactDepartment of Clinical Biochemistry
University Hospital of Aarhus
Outcome results
None listed