Clopidogrel And Ticagrelor in Healthy Subjects

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

Detailed Description
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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.

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

Conditions
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Pharmacodynamics

Intervention / Treatment
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* Drug: Ticagrelor 90 mg
* Drug: Clopidogrel 600 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor 90 mg<br>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: Ticagrelor 90 mg<br>* 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).<br>* Other names: Brilinta 90 mg;|
| Experimental: Clopidogrel 600 mg<br>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). | Drug: Clopidogrel 600 mg<br>* 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).<br>* Other names: Plavix 600 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity | Platelet reactivity will be measured using multiple platelet function tests, including, light transmission aggregometry (LTA), multiple electrode platelet aggregometry (MEA, Dynabyte Medical, Munich, Germany), VerifyNow (Accumetrics, San Diego, CA, USA), Total thrombus-formation analysis system (T-TAS®, Fujimori Kogyo, Japan). The platelet reactivity will be measured at 0.5, 2, 6, 24,26,120,122 hours after study drug administration. Percent inhibition is calculated using the following formula: % inhibition =[(baseline reactivity unit - gain(t) reactivity unit) / baseline reactivity unit] × 100. Baseline reactivity unit is the value before Ticagrelor or Clopidogrel loading dose. Gain(t) reactivity unit is the value for each subject at selected time points ( 0.5, 2, 6, 24,26,120,122 hours after study drug administration). | up to 122 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Clopidogrel, Platelet function test