Clopidogrel And Ticagrelor in Healthy Subjects

Phase 3

Completed

• Conditions: Pharmacodynamics
• Interventions: Drug: Ticagrelor 90 mg; Drug: Clopidogrel 600 mg

• Registration Number: NCT02086903
• Lead Sponsor: Dong-A University

Brief 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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ticagrelor 90 mg	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).
Clopidogrel 600 mg	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).

Primary Outcome Measures

Name	Time	Method
Platelet reactivity	up to 122 hours	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).

Trial Locations

Locations (1)

Dong A University Hospital; 🇰🇷 Busan, Korea, Republic of