The Effect of Ticagrelor or Clopidogrel on Endothelial Function During Acute and Chronic Treatment

NCT02580149 | Completed Phase 4

• 1 other identifier: FBF-Tica-Clopi
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate if treatment with ticagrelor can mitigate the transient loss of endothelium-dependent vasodilatation of the resistance vasculature following a short period of ischemia, compared with clopidogrel at standard clinical doses. The effect of ticagrelor or clopidogrel will be studied after a loading dose and after a two weeks period of regular intake on FBF in response to the vasodilators acetylcholine or nitroglycerin before and 10 min after a 20 min forearm ischemia, respectively.

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

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

  To test the effect of ticagrelor or clopidogrel 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 (2)

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

  Change of AUC before and 10 min after forearm ischemia

• (Expected) Peak plasma concentration of ticagrelor or clopidogrel

  2.5 h after IMP intake

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

Loading dose of 180 mg on day one, followed by a regular intake (90 mg twice daily) for 14 days

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Loading dose of 600 mg on day one, followed by a regular intake (75 mg once daily) for 14 days

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

Subjects will receive an oral loading dose of 180 mg ticagrelor on study day 1 followed by a maintenance dose of 90 mg twice daily for 14 days (until study day 15).

Also known as: Brilique

Ticagrelor

Clopidogrel DRUG

Subjects will receive a loading dose of 600 mg clopidogrel on the first study day followed by a maintenance dose of 75 mg once daily for 14 days

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Impaired liver function (AST, ALT, gGT, bilirubin \>2 x ULN)
• Impaired renal function (serum creatinine \> 1.3 mg/dl)
• 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

Sponsors & Collaborators

• Michael Wolzt, Prof. MD: lead

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Ischemia

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael Wolzt, Prof. MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

AU (1)