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
Conditions
Interventions
Trade Name: Brilique 90mg
Product Name: Brilique 90mg
Pharmaceutical Form: Tablet
CAS Number: 274693-27-5
Other descriptive name: TICAGRELOR
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
Male
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ß-TG, F1+2 and TAT in shed blood;Timepoint(s) of evaluation of this end point: at baseline and 3 hours after drug intake;Main Objective: • To evaluate the effect of ticagrelor + ASA in combination with dabigatran, rivaroxaban or phenprocoumon at steady state on markers of coagulation activation: prothrombin fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT), ß-thromboglobulin (ß-TG), D-Dimer, thromboxane B2 (TxB2), CD40 ligand (CD40L), p-Selectin in venous and shed blood. • To evaluate the effect of ticagrelor + ASA in combination with dabigatran, rivaroxaban or phenprocoumon at steady state on systemic coagulation in resting condition by assessment of the endogenous thrombin potential (ETP), on markers of coagulation (inhibition of factor Xa activity (anti FXa), activated partial thromboplastin time (aPTT), prothrombin time (PT) and Hemoclot®) and shed blood volume. ;Secondary Objective: • To evaluate the effect of phenprocoumon at a therapeutic INR range of 2 – 3 and of a single dose administration of dabigatran, rivaroxaban or ticagrelor on markers of coagulation activation: F1+2, TAT, ß-TG, D-Dimer, TxB2, CD40L, p-Selectin in venous and shed blood. • To evaluate the effect of phenprocoumon at a therapeutic INR range of 2 – 3 and of a single dose administration of dabigatran, rivaroxaban or ticagrelor on systemic coagulation in resting condition by assessment of ETP, on markers of coagulation (anti FXa activity, aPTT, PT & Hemoclot®) and shed blood volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • D-Dimer, TxB2, CD40L and p-Selectin in shed blood • ß-TG, F1+2, TAT, D-Dimer, TxB2, CD40L, p-Selectin, ETP, aPTT, PT, inhibition of factor Xa and Hemoclot® in venous blood ;Timepoint(s) of evaluation of this end point: shed blood parameter: at baseline and 3 hours after drug intake venous blood parameter: at baseline, 1, 2 and 3 hours after drug intake | — |
Countries
Austria
Contacts
Public ContactSecretary
Medical University of Vienna, Department of Clinical Pharmacology
Outcome results
None listed