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OpenTrials
Completed

NCT Number: NCT02910778

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

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).

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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.

Placebo

Drug

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.

Ticagrelor

Drug

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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