Antithrombotic triple therapy and its effects on coagulation markers in venous and shed blood

• Conditions: Investigation of coagulation markers in venous and shed blood of healthy male subjects that are treated with medicines used for patients with acute coronary syndrome and atrial fibrillation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001814-41-AT
• Lead Sponsor: Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

•Healthy male subjects; 18 – 40 years of age
•body mass index between 18 and 27 kg/m2
•Written informed consent
•Normal findings in medical & bleeding history
•Non-smoking behaviour

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Regular intake of any medication including OTC drugs within 2 weeks before IMP administration
•Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
•Known disorders with increased bleeding risk (e.g. peridontosis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
•Known sensitivity to common causes of bleeding (e.g. nasal)
•History of thromboembolism
•Impaired liver function (AST, ALT, GGT >3 x ULN, Bilirubin >2 x ULN)
•Impaired renal function (serum creatinine > 1.3 mg/dl)
•Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
•HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
•Systolic blood pressure below 100 mmHg or above 145 mmHg, diastolic blood pressure above 95 mmHg
•Known allergy against test agents
•Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
•Participation in another clinical trial during the preceding 3 weeks

Study & Design

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