NCT02910778

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

September 19, 2016

Last Update Submit

March 21, 2017

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation

    Change of the AUC before and 10 min after forearm ischemia

Study Arms (2)

Atorvastatin

EXPERIMENTAL

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

Drug: AtorvastatinDrug: Ticagrelor

Placebo

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Ticagrelor

Interventions

AtorvastatinDRUG

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.

Atorvastatin
PlaceboDRUG

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.

Placebo
TicagrelorDRUG
AtorvastatinPlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 29288055DERIVED

MeSH Terms

Conditions

Ischemia

Interventions

AtorvastatinTicagrelor

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 22, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

AU(1)