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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Ischemia

Treatments: Drug: Placebo; Drug: Ticagrelor; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02910778

FBF-Statin-Tica

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15

Treatment:

Drug: Ticagrelor

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15

Treatment:

Drug: Ticagrelor

Drug: Placebo