Acute Coronary Syndrome
Conditions
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.
Interventions
DRUGBrilinta
90mg bid as a treatment for Acute coronary syndrome. Dose and Duration can be adjusted by the primary physician.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
South Korea
Contacts
Primary ContactHyo soo Kim, MD, PhD
Outcome results
None listed