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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Michael Wolzt, Prof. MD
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

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

• 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