Clopidogrel And Ticagrelor in Healthy Subjects

Pharmacodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086903
• Other study ID #: COLLATERAL
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: January 2020
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacodynamics

Intervention

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).
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Dong A University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. Epub 2013 Jan 30. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity	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