Clopidogrel And Ticagrelor in Healthy Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Dong-A University
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University
ClinicalTrials.gov Identifier:
NCT02086903
First received: March 12, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Pharmacodynamics of Antiplatelet Agent.
Drug: Ticagrelor 90 mg
Drug: Clopidogrel 600 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Dong-A University:

Primary Outcome Measures:
  • Platelet reactivity [ Time Frame: up to 122 hours ] [ Designated as safety issue: No ]

    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).


Estimated Enrollment: 12
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Plavix 600 mg

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.

  Eligibility

Ages Eligible for Study:   19 Years to 59 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086903

Contacts
Contact: Moo Hyun Kim, M.D. +82-51-240-2976 kimmh@dau.ac.kr

Locations
Korea, Republic of
Dong A University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Moo Hyun Kim, M.D.    +82-51-240-2976    kimmh@dau.ac.kr   
Sponsors and Collaborators
Dong-A University
Investigators
Principal Investigator: Moo Hyun Kim, M.D. Dong-A University Hospital, Busan, Republic of Korea
  More Information

Publications:
Responsible Party: Moo Hyun Kim, MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital, Dong-A University
ClinicalTrials.gov Identifier: NCT02086903     History of Changes
Other Study ID Numbers: COLLATERAL
Study First Received: March 12, 2014
Last Updated: June 25, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Dong-A University:
Ticagrelor
Clopidogrel
Platelet function test

Additional relevant MeSH terms:
Ticagrelor
Clopidogrel
Ticlopidine
Adenosine
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 19, 2014