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Acute Coronary SyndromeNCT02521038

Use of Ticagrelor in Korean ACS Patients: The BRILIANT KOREA Registry

An observational study of Acute Coronary Syndrome, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with acute coronary syndrome (ACS) require platelet inhibition after treatment. P2Y12 receptor blockage is a well-known, proved method of urgent and effective blockade of the platelet activation, and is applied to the current practice protocol. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Brilinta
How many people
2,000 participants
Where
1 siteSouth Korea
Study dates
Jul 2015to Jan 2018
How long will I take part?
18 Months
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: ACS pateints who use Brilinta as a anti-platelet agent

Who may be able to join

  • Provision of informed consent prior to any study specific procedures. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
  • Patients who are taking ticagrelor and acetylsalicylic acid daily or Patients who are taking ticagrelor only according to label. All treatment modalities for Acute coronary syndrome (invasive and non-invasive) are allowed.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Hyo soo Kim, MD, PhD contact

+82-2-2072-2226

hyosoo@snu.ac.kr

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Hyo-Soo Kim, MD,PhD, 82-2-2072-2226

    Recruiting

Other trials in South Korea

About this study

Official title: The Use of BRILInta to Optimize ANTiplatelet Therapy (BRILIANT) Registry: The BRILIANT KOREA Registry

Patients with acute coronary syndrome (ACS) require platelet inhibition after treatment. P2Y12 receptor blockage is a well-known, proved method of urgent and effective blockade of the platelet activation, and is applied to the current practice protocol. Ticagrelor is a well-performing P2Y12 receptor blocking agent which is used in these patients. In the same matter, it is essential to prescribe the exact dosage to optimize efficacy within the safety limits. However current studies are based on Western countries, whereas there has been no Ticagrelor patient registry in East-Asia. Thus it is reasonable to study the use of Ticagrelor in a large registry of Korean ACS patients.

The BK registry is a Prospective, Open-label, Multi-center, Real world, Registry, with prospective registration of patients receiving the medication, Ticagrelor. All subjects are to be followed up for 18 months after diagnosis and treatment for ACS.

The purpose of this study is to observe and register clinical data including Major Adverse Cardiovascular Endpoints and any total bleeding occurrence in Korean ACS patients treated with Ticagrelor during 18 month follow-up. Also, the purpose includes to determine compliance of Ticagrelor during post-approval commercial use and to determine prescription pattern of Ticagrelor during post-approval commercial use.

Being tested
Brilinta
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrilintaDrug

    90mg bid as a treatment for Acute coronary syndrome. Dose and Duration can be adjusted by the primary physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with 'Major Adverse Cardiovascular endpoints'

    'Major Adverse Cardiovascular endpoints' assessment will be recorded as number of participants with 'Major Adverse Cardiovascular endpoints'. This measure is a composite outcome, which includes cardiovascular death, myocardial infarction, stroke, stent thrombosis.

    Measured: 18 months

  2. Number of participants with Bleeding events

    Bleeding event assessment will be recorded as number of participants with Bleeding events. Assessment will be done by the investigator(s) at each routine out-patient follow-up period. Bleeding events will be analyzed according to the 'PLATO bleeding criteria'.

    Measured: 18 months

Secondary outcomes (3)

  1. Compliance of Brilinta

    Compliance assessment will be recorded as 'taken pills per prescribed pills'. This will be assessed by history taking, self-reports of pill counts. Reports from the 'Korean Health Insurance Review \& Assessment Service' can be used to assess the patients' compliance, by the prescription refill rate. Assessment will be done by the investigator(s) at each routine out-patient follow-up period.

    Measured: 12 months

  2. Duration of prescribed Brilinta

    'Duration of prescribed Brilinta' assessment will be recorded as 'months', which is the actual period Brilinta is prescribed. This will be assessed by hospital records of Brilinta prescriptions. Reports from the 'Korean Health Insurance Review \& Assessment Service' can be used to assess the prescription refill rate.

    Measured: 12 months

  3. Dosage of prescribed Brilinta

    'Dosage of prescribed Brilinta' assessment will be recorded as 'mg', which is the actual dosage Brilinta is prescribed. This will be assessed by hospital records of Brilinta prescriptions. Reports from the 'Korean Health Insurance Review \& Assessment Service' can be used to assess the prescription.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02521038
Sponsor's protocol ID
BK Registry
Status last verified
Oct 2017
First submitted
4 Aug 2015
Last updated
9 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Mahaffey KW, Held C, Wojdyla DM, James SK, Katus HA, Husted S, Steg PG, Cannon CP, Becker RC, Storey RF, Khurmi NS, Nicolau JC, Yu CM, Ardissino D, Budaj A, Morais J, Montgomery D, Himmelmann A, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol. 2014 Apr 22;63(15):1493-9. doi: 10.1016/j.jacc.2014.01.038. Epub 2014 Feb 19.

    PubMed 24561148

  • Wallentin L, Lindholm D, Siegbahn A, Wernroth L, Becker RC, Cannon CP, Cornel JH, Himmelmann A, Giannitsis E, Harrington RA, Held C, Husted S, Katus HA, Mahaffey KW, Steg PG, Storey RF, James SK; PLATO study group. Biomarkers in relation to the effects of ticagrelor in comparison with clopidogrel in non-ST-elevation acute coronary syndrome patients managed with or without in-hospital revascularization: a substudy from the Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2014 Jan 21;129(3):293-303. doi: 10.1161/CIRCULATIONAHA.113.004420. Epub 2013 Oct 29.

    PubMed 24170388

  • Bansilal S, Bonaca MP, Sabatine MS. Ticagrelor for acute coronary syndromes. Expert Rev Cardiovasc Ther. 2013 Nov;11(11):1473-84. doi: 10.1586/14779072.2013.839205. Epub 2013 Oct 23.

    PubMed 24147518

  • Steg PG, Harrington RA, Emanuelsson H, Katus HA, Mahaffey KW, Meier B, Storey RF, Wojdyla DM, Lewis BS, Maurer G, Wallentin L, James SK; PLATO Study Group. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial. Circulation. 2013 Sep 3;128(10):1055-65. doi: 10.1161/CIRCULATIONAHA.113.002589. Epub 2013 Jul 30.

    PubMed 23900047

  • Berger JS. Aspirin, clopidogrel, and ticagrelor in acute coronary syndromes. Am J Cardiol. 2013 Sep 1;112(5):737-45. doi: 10.1016/j.amjcard.2013.04.055. Epub 2013 Jun 7.

    PubMed 23751937

  • Montalescot G, Lassen JF, Hamm CW, Lapostolle F, Silvain J, ten Berg JM, Cantor WJ, Goodman SG, Licour M, Tsatsaris A, van't Hof AW. Ambulance or in-catheterization laboratory administration of ticagrelor for primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: rationale and design of the randomized, double-blind Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) study. Am Heart J. 2013 Apr;165(4):515-22. doi: 10.1016/j.ahj.2012.12.015. Epub 2013 Feb 13.

    PubMed 23537967

  • Wittfeldt A, Emanuelsson H, Brandrup-Wognsen G, van Giezen JJ, Jonasson J, Nylander S, Gan LM. Ticagrelor enhances adenosine-induced coronary vasodilatory responses in humans. J Am Coll Cardiol. 2013 Feb 19;61(7):723-7. doi: 10.1016/j.jacc.2012.11.032. Epub 2013 Jan 9.

    PubMed 23312702

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Seoul National University Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2017. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyo soo Kim, MD, PhD (+82-2-2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with 'Major Adverse Cardiovascular endpoints' (time frame: 18 months). 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 NCT02521038, which also lists 7 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 9 Oct 2017.

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