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Clopidogrel And Ticagrelor in Healthy Subjects

Information source: Dong-A University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacodynamics of Antiplatelet Agent.

Intervention: Ticagrelor 90 mg (Drug); Clopidogrel 600 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dong-A University

Official(s) and/or principal investigator(s):
Moo Hyun Kim, M.D., Principal Investigator, Affiliation: Dong-A University Hospital, Busan, Republic of Korea

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Platelet reactivity

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

Minimum age: 19 Years. Maximum age: 59 Years. Gender(s): Male.

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 ╬╝mol/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

Locations and Contacts

Dong A University Hospital, Busan 602-715, Korea, Republic of
Additional Information

Related publications:

Teng R, Mitchell P, Butler K. Effect of age and gender on pharmacokinetics and pharmacodynamics of a single ticagrelor dose in healthy individuals. Eur J Clin Pharmacol. 2012 Aug;68(8):1175-82. doi: 10.1007/s00228-012-1227-4. Epub 2012 Feb 25.

Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.

Kim MH, Zhang HZ, Jung DK. Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers. Circ J. 2013;77(5):1253-9. Epub 2013 Jan 30.

Starting date: February 2014
Last updated: December 30, 2014

Page last updated: August 23, 2015

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