Clopidogrel And Ticagrelor in Healthy Subjects

NCT ID: NCT02086903

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

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.

Conditions

Pharmacodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Ticagrelor 90 mg

Intervention Type: DRUG

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).

Group Type: EXPERIMENTAL

Clopidogrel 600 mg

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Brilinta 90 mg; Plavix 600 mg

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A University

OTHER

Sponsor Role: lead

Responsible Party

Moo Hyun Kim

MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moo Hyun Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital, Busan, Republic of Korea

Locations

Dong A University Hospital

Busan, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 22367426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19923168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23363643 (View on PubMed)

Other Identifiers

COLLATERAL

Identifier Type: -

Identifier Source: org_study_id