Clopidogrel And Ticagrelor in Healthy Subjects

Phase 3CompletedNCT02086903

Dong-A University12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Pharmacodynamics

Interventions

Ticagrelor 90 mgDRUG

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).

Clopidogrel 600 mgDRUG

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).

Eligibility

Sex: MALEMin age: 19 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dong A University Hospital

Busan, South Korea

Outcomes

Primary Outcomes

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).

Time frame: up to 122 hours

Data from ClinicalTrials.gov

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