Clopidogrel And Ticagrelor in Healthy Subjects

NCT02086903 | Completed Phase 3 DMC

• 1 other identifier: COLLATERAL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacodynamics

Keywords

Ticagrelor; Clopidogrel; Platelet function test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ticagrelor 90 mg

EXPERIMENTAL

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

Clopidogrel 600 mg

EXPERIMENTAL

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

Interventions

Ticagrelor 90 mg 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).

Also known as: Brilinta 90 mg

Ticagrelor 90 mg

Clopidogrel 600 mg 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).

Also known as: Plavix 600 mg

Clopidogrel 600 mg

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

Dong A University Hospital

Busan, 602-715, South Korea

Location

Related Publications (3)

• 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.

  PMID: 22367426 BACKGROUND

• 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.

  PMID: 19923168 BACKGROUND

• 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.

  PMID: 23363643 BACKGROUND

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Moo Hyun Kim, M.D.

  Dong-A University Hospital, Busan, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 13, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

KR (1)