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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02910778
Other study ID # FBF-Statin-Tica
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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