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

Ischemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910778
• Other study ID #: FBF-Statin-Tica
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2016
• Last updated: March 21, 2017
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia

Intervention

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.
• 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.
• Ticagrelor

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Acetylcholine (ACh) induced vasodilatation	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	Change of the AUC before and 10 min after forearm ischemia
Secondary	Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation	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	Change of the AUC before and 10 min after forearm ischemia