NCT02086903

Clopidogrel And Ticagrelor in Healthy Subjects

Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dong-A University · Academic / Other
• Sex: Male
• Age: 19 Years – 59 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.

Detailed description

Consist with previous study Ticagrelor had greater, faster and more the platelet inhibition effect than Clopidogrel in both healthy subjects and stable coronary artery disease patients. Moreover, Asian subjects exposed higher active metabolite and stronger pharmacodynamics response than European subjects with same oral dose of antiplatelet agent. However, previous report comparing the efficacy and safety of Ticagrelor and Clopidogrel in healthy Asian ethnicity is lacking. Therefore, the aim of this study is to evaluate the pharmacodynamic responses of a lower Ticagrelor dose using laboratory platelet function tests in healthy Korean volunteers.

Conditions

• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Ticagrelor 90 mg	The subjects administer Ticagrelor 90 mg as loading dose (LD) follow by 90 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Clopidogrel 600 mg as LD follow by 75 mg/day as MD for 5 days).
DRUG	Clopidogrel 600 mg	The subjects administer Clopidogrel 600 as loading dose (LD) follow by 75 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Ticagrelor 90 mg/day as LD, follow by 90 mg/day as MD for 5 days).

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2014-03-13
• Last updated: 2020-01-29

Locations

1 site across 1 country: South Korea