PharmacodynamicsPhase 3NCT02086903
Clopidogrel And Ticagrelor in Healthy Subjects
A Phase 3 study testing Ticagrelor 90 mg and Clopidogrel 600 mg in people with Pharmacodynamics, run by Dong-A University at 1 site in South Korea.
Trial summary
To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent. Read more about this study
- Who is it for?
- Ages 19 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamics
- What is being tested?
- Ticagrelor 90 mg and Clopidogrel 600 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects
To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.
Read the 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
- Being tested
- Ticagrelor 90 mg, Clopidogrel 600 mg
- Keywords
- Ticagrelor, Clopidogrel, Platelet function test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90 mgDrug
Also called Brilinta 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 mgDrug
Also called Plavix 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Clopidogrel 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 122 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PharmacodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo Hyun Kim, Dong-A University
- Investigators
- Moo Hyun Kim, M.D., Principal investigator, Dong-A University Hospital, Busan, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086903
- Sponsor's protocol ID
- COLLATERAL
- Status last verified
- Jan 2020
- First submitted
- 12 Mar 2014
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22367426Gurbel 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.
PubMed 19923168Kim 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.
PubMed 23363643
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02086903
- Acronym / sponsor ID
- COLLATERAL
- Conditions
- Pharmacodynamics
- Keywords
- Ticagrelor, Clopidogrel, Platelet function test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor 90 mg | Experimental | Drug: Ticagrelor 90 mgThe 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 | Experimental | Drug: Clopidogrel 600 mgThe 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). |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor 90 mgAlso: Brilinta 90 mgThe 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 mgAlso: Plavix 600 mgThe 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 |
Primary outcome
Platelet reactivity
Time frame: up to 122 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 22367426Teng 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.
- Background: PubMed 19923168Gurbel 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.
- Background: PubMed 23363643Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo Hyun Kim, M.D. principal investigator
Dong-A University Hospital, Busan, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor 90 mg and Clopidogrel 600 mg in people with Pharmacodynamics, run by Dong-A University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (time frame: up to 122 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.