The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Atorvastatin; Atorvastatin Calcium; Ticagrelor

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

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