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

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ClinicalTrials.gov Identifier: NCT02910778
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Wolzt, Prof. MD, Medical University of Vienna

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).

Condition or disease Intervention/treatment Phase
Ischemia Drug: Atorvastatin Drug: Placebo Drug: Ticagrelor Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atorvastatin
80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15
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.

Drug: Ticagrelor
Placebo Comparator: Placebo
Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15
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.

Drug: Ticagrelor



Primary Outcome Measures :
  1. Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Acetylcholine (ACh) induced vasodilatation [ Time Frame: Change of the AUC before and 10 min after forearm ischemia ]
    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 :
  1. Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation [ Time Frame: Change of the AUC before and 10 min after forearm ischemia ]
    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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910778


Locations
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Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Wolzt, Prof. MD, Prof. MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02910778     History of Changes
Other Study ID Numbers: FBF-Statin-Tica
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Ticagrelor
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs