EUCTR2012-001814-41-AT
Active, not recruiting
Not Applicable
A prospective, randomized, controlled, analyst-blinded, parallel group study to investigate the effect of antithrombotic triple therapy with ticagrelor and acetylsalicylic acid in combination with dabigatran or rivaroxaban or phenprocoumon on markers of coagulation activation in venous and shed blood in healthy male subjects - Antithrombotic triple therapy
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie0 sites60 target enrollmentApril 30, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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