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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02910778
• Date of registration: 19/09/2016
• Prospective Registration: Yes
• Primary sponsor: Medical University of Vienna
• Public title: The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Effect of Atorvastatin Treatment for 14 Days in Combination With an Acute Dose of Ticagrelor on Ischemia Reperfusion Induced Endothelial Dysfunction of the Forearm Vasculature in Healthy Male Subjects
• Date of first enrolment: October 2016
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02910778
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Austria

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Ischemia

Intervention(s)

Drug: Placebo

Drug: Ticagrelor

Drug: Atorvastatin

Primary Outcome(s)

Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Acetylcholine (ACh) induced vasodilatation [Time Frame: Change of the AUC before and 10 min after forearm ischemia]

Secondary Outcome(s)

Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation [Time Frame: Change of the AUC before and 10 min after forearm ischemia]

Secondary ID(s)

FBF-Statin-Tica

Source(s) of Monetary Support

Please refer to primary and secondary sponsors