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Clopidogrel And Ticagrelor in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02086903
First Posted: March 13, 2014
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University
  Purpose
To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.

Condition Intervention Phase
Pharmacodynamics Drug: Ticagrelor 90 mg Drug: Clopidogrel 600 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 Moo Hyun Kim, Dong-A University:

Primary Outcome Measures:
  • 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).


Enrollment: 12
Study Start Date: February 2014
Study Completion Date: May 2014
Primary Completion Date: April 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

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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086903


Locations
Korea, Republic of
Dong A University Hospital
Busan, Korea, Republic of, 602-715
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
First Submitted: March 12, 2014
First Posted: March 13, 2014
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Moo Hyun Kim, Dong-A University:
Ticagrelor
Clopidogrel
Platelet function test

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Ticagrelor
Adenosine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists