Acute Coronary SyndromesNCT01611272
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 23 sites in South Korea.
Trial summary
To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy… Read more about this study
- Who is it for?
- Ages 19 to 130 years
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 3,402 participants
- Where
- 23 sitesSouth Korea
- Study dates
- 30 Apr 2013to 20 Jul 2016
- 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 19 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who take Brilinta according to the local approval condition
Who may be able to join
- Patients with Acute Coronary Syndromes
- Patients who are taking ticagrelor and ASA daily(75-150mg), or Patients who are taking ticagrelor only(In the case that the patients have contraindication with ASA. Contraindication should be recorded in accordance with local PI on CRFs)
- Patients who have signed the Data release consent form prior to enrollment in this surveillance
Who cannot join
- Patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage
- Patients with pathological hemorrhage at the time of administration
- Patients being administrated strong CYP3A4 inhibitors
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
South Korea23 sites
Research Site
Andong, Gyeongsangbuk-do
Research Site
Ansan-si, Gyeonggi-do
Research Site
Anyang-si, Gyeonggi-do
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Busan
Research Site
Cheonan-si, Chungcheongnam-do
Research Site
Chuncheon, Gangwon-do
Research Site
Daegu
Research Site
Daejeon
Research Site
Gimhae, Gyeongsangnam-do
Research Site
Goyang-si, Gyeonggi-do
Research Site
Gumi, Gyeongsangbuk-do
Research Site
Gwangju
Research Site
Iksan-si, Jeollabuk-do
Research Site
Incheon
Research Site
Jeonju, Jeollabuk-do
Research Site
Koyang-shi, Gyeonggi-do
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Suncheon-si, Jeollanam-do
Research Site
Suwon, Gyeonggi-do
Research Site
Ulsan
Research Site
Wŏnju, Gangwon-do
About this study
To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.
Read the detailed description
A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
- Conditions
- Acute Coronary Syndromes
- Keywords
- Unstable angina
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Unstable angina, Non ST-segment Elevation Myocardial Infarction or ST-segment elevation myocardial infarction including patients managed medically, and those who are managed with percutaneous coronary intervention or coronary artery by-pass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hemorrhage events
Measured: up to 54 months
Number of other AEs
Measured: up to 54 months
Secondary outcomes (3)
Number of Stroke events
for efficacy
Measured: up to 54 months
Number of Cardiovascular (CV) related deaths events
for efficacy
Measured: up to 54 months
Number of Myocardial Infarction events
for efficacy
Measured: up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study start30 Apr 2013
- Primary completion20 Jul 2016
- Study completion20 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JooWon Lee, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611272
- Sponsor's protocol ID
- D5130L00019
- Status last verified
- Jul 2017
- First submitted
- 25 May 2012
- Last updated
- 13 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
- ClinicalTrials.gov ID
- NCT01611272
- Acronym / sponsor ID
- D5130L00019
- Conditions
- Acute Coronary Syndromes
- Keywords
- Unstable angina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,402 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2013 (actual)
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 20 Jul 2016 (actual)
- First posted
- 4 Jun 2012 (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.
To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.
Detailed description
A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Unstable angina, Non ST-segment Elevation Myocardial Infarction or ST-segment elevation myocardial infarction including patients managed medically, and those who are managed with percutaneous coronary intervention or coronary artery by-pass grafting |
Who may qualify
- Ages
- 19 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who take Brilinta according to the local approval condition
Key inclusion criteria (3 listed)
- Patients with Acute Coronary Syndromes
- Patients who are taking ticagrelor and ASA daily(75-150mg), or Patients who are taking ticagrelor only(In the case that the patients have contraindication with ASA. Contraindication should be recorded in accordance with local PI on CRFs)
- Patients who have signed the Data release consent form prior to enrollment in this surveillance
Key exclusion criteria (3 listed)
- Patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage
- Patients with pathological hemorrhage at the time of administration
- Patients being administrated strong CYP3A4 inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Hemorrhage events
Time frame: up to 54 months
Number of other AEs
Time frame: up to 54 months
3 secondary outcomes
Number of Stroke events
Time frame: up to 54 months
Number of Cardiovascular (CV) related deaths events
Time frame: up to 54 months
Number of Myocardial Infarction events
Time frame: up to 54 months
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 13 Jul 2017.
- CSR SynopsisLink provided by the sponsor.
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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.
JooWon Lee study director
AstraZeneca Korea
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 23 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 3 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 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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.
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?
Number of Hemorrhage events (time frame: up to 54 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?
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 13 Jul 2017.