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

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02521038
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-08
• Study First Posted: 2015-08-13
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with 'Major Adverse Cardiovascular endpoints'	18 months	'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.
Number of participants with Bleeding events	18 months	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'.

Secondary Outcome Measures

Name	Time	Method
Compliance of Brilinta	12 months	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.
Dosage of prescribed Brilinta	12 months	'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.
Duration of prescribed Brilinta	12 months	'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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of