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Completed

NCT Number: NCT02086903

Clopidogrel And Ticagrelor in Healthy Subjects

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

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Key information

Conditions

Pharmacodynamics

Age range

19 year–59 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Dong A University Hospital

Busan, 602-715, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 90 MG

Drug

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).

Other names: Brilinta 90 mg

Clopidogrel 600 mg

Drug

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).

Other names: Plavix 600 mg

Primary outcomes

  1. Platelet reactivity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2014
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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