Clopidogrel And Ticagrelor in Healthy Subjects

Dong-A University

Status and phase: Completed; Phase 3

Conditions: Pharmacodynamics

Treatments: Drug: Ticagrelor 90 mg; Drug: Clopidogrel 600 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02086903

COLLATERAL

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 19 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 12 healthy men
• Aged between 19 and 59 years
• Body mass index (BMI) is between 18.5 and 29.9 kg/m2
• Baseline maximal platelet aggregation (MPA) 10 μmol/L ADP is more than 65%
• To screen for standard results on usual clinical tests

Exclusion criteria

• A history of bleeding within 6 months
• Bleeding diathesis
• Hemoglobin < 12g/dl
• History of antiplatelet or anticoagulation treatment within 1 month
• contraindication to the study drug
• Severe hepatic dysfunction (serum liver enzyme or bilirubin >3 times normal limit)
• Patients with hereditary disease such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption
• Previous experience of clinical trials within three months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Ticagrelor 90 mg

Experimental group

Description:

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).

Treatment:

Drug: Ticagrelor 90 mg

Clopidogrel 600 mg

Experimental group

Description:

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).

Treatment:

Drug: Clopidogrel 600 mg