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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Atorvastatin

80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type 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.

Ticagrelor

Intervention Type DRUG

Placebo

Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Intervention Type DRUG

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Ticagrelor

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes