Measurement of Aspirin Concentration and Effect - MACE

Phase 1

• Conditions: Healthy volunteers (Prophylaxis of arterial thrombosis); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 20.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations

• Registration Number: EUCTR2017-005068-16-DK
• Lead Sponsor: niversity Hospital of Aarhus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified