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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521038
• Other study ID #: BK Registry
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2015
• Last updated: October 6, 2017
• Start date: July 2015
• Est. completion date: January 2018

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: Hyo soo Kim, MD, PhD
• Phone: +82-2-2072-2226
• Email: hyosoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Exclusion Criteria:

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Primary	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'.	18 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months