Clinical trial NCT02086903: Clopidogrel And Ticagrelor in Healthy Subjects
Official title: Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharmacodynamics
Keywords: Ticagrelor
Clopidogrel
Platelet function test
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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 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

Primary outcomes:
measure: Platelet reactivity
timeFrame: up to 122 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong A University Hospital
Study officials:
affiliation: Dong-A University Hospital, Busan, Republic of Korea
name: Moo Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.