Ischemia
Conditions
Brief summary
To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced vasodilatation of the forearm resistance vasculature as assessed by forearm blood flow (FBF) measurement before and 10 min after a 20 min forearm ischemia. The area under the dose-effect curve (AUC) of different ACh doses will be calculated and compared between treatment groups (atorvastatin + ticagrelor vs. placebo + ticagrelor) and different time points (pre-ischemia vs. post-ischemia).
Interventions
DRUGAtorvastatin
Subjects will receive 80 mg atorvastatin once daily for 14 days (until study day 15). On study day 15, 80 mg atorvastatin in combination with a loading dose of 180 mg ticagrelor will be administered.
DRUGPlacebo
Subjects will receive placebo once daily for 14 days (until study day 15). On study day 15, placebo in combination with a loading dose of 180 mg ticagrelor will be administered.
DRUGTicagrelor
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Exclusion criteria
* Regular intake of any medication including OTC drugs and herbals 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 * History of occlusive vascular diseases * History of vascular anomalies * History of hypercholesterolemia * History of myopathy * Impaired liver function (AST, ALT, gGT, bilirubin \> 3 x ULN) * Impaired renal function (serum creatinine \> 1.3 mg/dl) * Elevated creatinine-kinase or serum-myoglobin (\> 3 x ULN) * 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 above 145 mmHg, diastolic blood pressure above 95 mmHg * Known allergy against any test agent under study * 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 | Description |
|---|---|---|
| Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Acetylcholine (ACh) induced vasodilatation | Change of the AUC before and 10 min after forearm ischemia | To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced vasodilatation of the forearm resistance vasculature as assessed by FBF measurement before and 10 min after a 20 min forearm ischemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation | Change of the AUC before and 10 min after forearm ischemia | To test the effect of atorvastatin or placebo in combination with ticagrelor on GTN-induced vasodilatation of the forearm resistance vasculature as assessed by FBF measurement before and 10 min after a 20 min forearm ischemia |
Countries
Austria
Outcome results
None listed