The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
- Registration Number
- NCT02910778
- Lead Sponsor
- Medical University of Vienna
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15 Atorvastatin Atorvastatin 80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15 Atorvastatin Ticagrelor 80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15 Placebo Ticagrelor Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Medical University of Vienna, Department of Clinical Pharmacology
🇦🇹Vienna, Austria