Acute Coronary SyndromePhase 4TICA KOREANCT02094963
Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome and Myocardial Ischemia, run by Seung-Jung Park at 10 sites in South Korea.
Trial summary
The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 5 Jul 2014to 1 Nov 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and more
- Index event of non-ST or ST segment elevation ACS
- Provision of signed informed consent
Who cannot join
- Hypersensitivity to aspirin or ticagrelor
- Oral anticoagulation therapy that cannot be stopped
- Treated with thrombolysis within 24hrs
- Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
- Any life-threatening condition with life expectancy less than 6months
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- Mental condition (dementia, alcohol or drug abuse) which may be affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study
- High risk due to malignant hypertension
- The conditions associated with increased risk of bradycardiac events
- Subjects with severe liver disease
- Subjects requiring dialysis
- Increased bleeding risk
- History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days
- Thrombocytopenia or leukopenia
- Positive pregnancy test or is known to be pregnant
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Dongguk University Gyeongju Hospital
Gyeongju
Inje University Ilsan Paik Hospital
Ilsan
Gachon University Gil Hospital
Incheon
ChonBuk National University Hospital
Jeonju
Dong-A Medical Center
Pusan
Inje University Pusan Paik Hospital
Pusan
Asan Medical Center
Seoul, Songpa-gu, 138-736
Ulsan University Hospital
Ulsan
About this study
Official title: A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial
The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.
- Conditions
- Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Angina Pectoris
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- acute coronary syndrome, coronary disease, coronary artery disease
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Angina Pectoris, Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
180mg loading and 90mg bid
ClopidogrelDrug
600mg loading and 75mg qd
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Not described Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Not described Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first occurrence of any bleeding event
Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)
Measured: 1year
The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
Measured: 1year
Secondary outcomes (16)
The time to first occurrence of major bleeding event
by PLAtelet inhibition and patient Outcomes(PLATO) criteria
Measured: 1year
The time to first occurrence of minor bleeding event
by PLAtelet inhibition and patient Outcomes(PLATO) criteria
Measured: 1year
The time to first occurrence of major bleeding event or minor bleeding event
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
Measured: 1year
The time to first occurrence of major bleeding event
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
Measured: 1year
The time to first occurrence of minor bleeding event
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
Measured: 1year
The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5
By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events
Measured: 1year
The time of first occurrence of discontinuation of study medication from any bleeding event
Measured: 1year
Non serious adverse events
Measured: 1year
Adverse events following discontinuation of study medication
Measured: 1year
Serious adverse events
Measured: 1year
The time to first occurrence of death from vascular causes
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes
Measured: 1year
The time to first occurrence of myocardial infarction
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction
Measured: 1year
The time to first occurrence of stroke
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke
Measured: 1year
The time to occurrence of composite events
The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)
Measured: 1year
The time to occurrence of death from any cause
Measured: 1year
Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study start5 Jul 2014
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094963
- Sponsor's protocol ID
- AMCCV2013-14
- Acronym
- TICA KOREA
- Status last verified
- Nov 2018
- First submitted
- 10 Mar 2014
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Publications
Jang MH, Kim AR, Kim T, Oh HJ, Lee JH, Lee YJ, Kim S, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; TICAKOREA Investigators. Age- and Sex-Specific Disparities in Outcomes After Ticagrelor Versus Clopidogrel in East Asian Patients. Am J Cardiol. 2023 Nov 15;207:237-244. doi: 10.1016/j.amjcard.2023.08.124. Epub 2023 Sep 26.
PubMed 37757520Lee J, Kim MJ, Kim M, Park J, Kim H, Cho S, Choi Y, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park SJ, Park DW; TICAKOREA Study Investigators. Validation of Academic Research Consortium for High Bleeding Risk Definition in East-Asian Patients. JACC Asia. 2023 Feb 7;3(3):390-399. doi: 10.1016/j.jacasi.2022.11.012. eCollection 2023 Jun.
PubMed 37323862Choi Y, Kang DY, Lee J, Lee J, Kim M, Kim H, Park J, Cho S, Lee J, Cha SJ, Kim TO, Lee PH, Ahn JM, Park SJ, Park DW; TICA KOREA Investigators. Ticagrelor Versus Clopidogrel in East Asian Patients With Acute Coronary Syndrome and Diabetes Mellitus. JACC Asia. 2022 Nov 15;2(6):666-674. doi: 10.1016/j.jacasi.2022.07.005. eCollection 2022 Nov.
PubMed 36444315Park DW, Kwon O, Jang JS, Yun SC, Park H, Kang DY, Ahn JM, Lee PH, Lee SW, Park SW, Choi SW, Lee SG, Yoon HJ, Ahn T, Kim MH, Nah DY, Lee SY, Chae JK, Park SJ; TICAKOREA Investigators. Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1865-1877. doi: 10.1161/CIRCULATIONAHA.119.041766. Epub 2019 Sep 25.
PubMed 31553203
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial
- ClinicalTrials.gov ID
- NCT02094963
- Acronym / sponsor ID
- TICA KOREA / AMCCV2013-14
- Conditions
- Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Angina Pectoris
- Keywords
- acute coronary syndrome, coronary disease, coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 5 Jul 2014 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 24 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.
The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor |
| Clopidogrel | Active comparator | Drug: Clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and more
- Index event of non-ST or ST segment elevation ACS
- Provision of signed informed consent
Key exclusion criteria (15 listed)
- Hypersensitivity to aspirin or ticagrelor
- Oral anticoagulation therapy that cannot be stopped
- Treated with thrombolysis within 24hrs
- Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
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 |
|---|---|---|
| Ticagrelor180mg loading and 90mg bid | Drug | Ticagrelor |
| Clopidogrel600mg loading and 75mg qd | Drug | Clopidogrel |
Primary outcome
The time to first occurrence of any bleeding event
Time frame: 1year
Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)
The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
Time frame: 1year
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
16 secondary outcomes
The time to first occurrence of major bleeding event
Time frame: 1year
The time to first occurrence of minor bleeding event
Time frame: 1year
The time to first occurrence of major bleeding event or minor bleeding event
Time frame: 1year
The time to first occurrence of major bleeding event
Time frame: 1year
The time to first occurrence of minor bleeding event
Time frame: 1year
The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5
Time frame: 1year
The time of first occurrence of discontinuation of study medication from any bleeding event
Time frame: 1year
Non serious adverse events
Time frame: 1year
Adverse events following discontinuation of study medication
Time frame: 1year
Serious adverse events
Time frame: 1year
The time to first occurrence of death from vascular causes
Time frame: 1year
The time to first occurrence of myocardial infarction
Time frame: 1year
The time to first occurrence of stroke
Time frame: 1year
The time to occurrence of composite events
Time frame: 1year
The time to occurrence of death from any cause
Time frame: 1year
Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke.
Time frame: 1year
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 30 Nov 2018.
- Derived from this study: PubMed 37757520Jang MH, Kim AR, Kim T, Oh HJ, Lee JH, Lee YJ, Kim S, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; TICAKOREA Investigators. Age- and Sex-Specific Disparities in Outcomes After Ticagrelor Versus Clopidogrel in East Asian Patients. Am J Cardiol. 2023 Nov 15;207:237-244. doi: 10.1016/j.amjcard.2023.08.124. Epub 2023 Sep 26.
- Derived from this study: PubMed 37323862Lee J, Kim MJ, Kim M, Park J, Kim H, Cho S, Choi Y, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park SJ, Park DW; TICAKOREA Study Investigators. Validation of Academic Research Consortium for High Bleeding Risk Definition in East-Asian Patients. JACC Asia. 2023 Feb 7;3(3):390-399. doi: 10.1016/j.jacasi.2022.11.012. eCollection 2023 Jun.
- Derived from this study: PubMed 36444315Choi Y, Kang DY, Lee J, Lee J, Kim M, Kim H, Park J, Cho S, Lee J, Cha SJ, Kim TO, Lee PH, Ahn JM, Park SJ, Park DW; TICA KOREA Investigators. Ticagrelor Versus Clopidogrel in East Asian Patients With Acute Coronary Syndrome and Diabetes Mellitus. JACC Asia. 2022 Nov 15;2(6):666-674. doi: 10.1016/j.jacasi.2022.07.005. eCollection 2022 Nov.
- Derived from this study: PubMed 31553203Park DW, Kwon O, Jang JS, Yun SC, Park H, Kang DY, Ahn JM, Lee PH, Lee SW, Park SW, Choi SW, Lee SG, Yoon HJ, Ahn T, Kim MH, Nah DY, Lee SY, Chae JK, Park SJ; TICAKOREA Investigators. Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1865-1877. doi: 10.1161/CIRCULATIONAHA.119.041766. Epub 2019 Sep 25.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome and Myocardial Ischemia, run by Seung-Jung Park at 10 sites 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 3 inclusion and 15 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 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The time to first occurrence of any bleeding event (time frame: 1year). The study lists 2 primary outcomes in all. 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 NCT02094963, which also lists 4 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 30 Nov 2018.