Clopidogrel And Ticagrelor in Healthy Subjects

January 28, 2020 updated by: Moo Hyun Kim, Dong-A University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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).
Other Names:
  • Brilinta 90 mg
Experimental: 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).
Drug: 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).
Other Names:
  • Plavix 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 122 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Investigators

  • Principal Investigator: Moo Hyun Kim, M.D., Dong-A University Hospital, Busan, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLLATERAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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