Back to resultsThe Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
Primary Purpose
Ischemia
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Ischemia
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atorvastatin
Placebo
Arm Description
80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15
Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02910778
First Posted
September 19, 2016
Last Updated
March 21, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02910778
Brief Title
The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Primary Outcome Measure Information:
Title
Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Acetylcholine (ACh) induced vasodilatation
Description
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
Time Frame
Change of the AUC before and 10 min after forearm ischemia
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation
Description
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
Time Frame
Change of the AUC before and 10 min after forearm ischemia
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29288055
Citation
Weisshaar S, Litschauer B, Kerbel T, Wolzt M. Atorvastatin combined with ticagrelor prevent ischemia-reperfusion induced vascular endothelial dysfunction in healthy young males - A randomized, placebo-controlled, double-blinded study. Int J Cardiol. 2018 Mar 15;255:1-7. doi: 10.1016/j.ijcard.2017.12.067. Epub 2017 Dec 24.
Results Reference
derived
Learn more about this trial
The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
We'll reach out to this number within 24 hrs