NCT02910778

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Ischemia

Interventions

Type	Name	Description
DRUG	Atorvastatin	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.
DRUG	Placebo	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.
DRUG	Ticagrelor

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2016-09-22
• Last updated: 2017-03-22

Locations

1 site across 1 country: Austria