Non ST-elevation Myocardial InfarctionPhase 4NCT02406248
Brilinta Taiwan Post Approval Safety Study
A Phase 4 study testing Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) in people with Non ST-elevation Myocardial Infarction, run by AstraZeneca at 13 sites in Taiwan.
Trial summary
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non ST-elevation Myocardial Infarction
- What is being tested?
- Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 13 sitesTaiwan
- Study dates
- 23 Apr 2015to 9 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 20 years
- Patient who is considered as ethnic Taiwanese
- Index event of non-ST elevation myocardial infarction
Who cannot join
- Contraindication or other reason that ticagrelor should not be administered
- Index event is an acute complication of Percutaneous coronary intervention (PCI)
- Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
- Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
- Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Taiwan13 sites
Research Site
Changhua, 50006
Research Site
Hsinchu, 300
Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 81362
Research Site
Niao-Song-Shiang, 833
Research Site
Taichung
Research Site
Tainan, 704
Research Site
Tainan County
Research Site
Taipei, 104
Research Site
Taipei, 11101
Research Site
Taipei, 11217
Research Site
Taipei, 11220
Research Site
Taipei, 22060
About this study
Official title: A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Cumulative Incidence of Major Cardiovascular Events of Ticagrelor in Taiwanese Patients With Non ST-segment Elevation Myocardial Infarction
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction
Read the detailed description
This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.
- Conditions
- Non ST-elevation Myocardial Infarction
- Being tested
- Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
- Keywords
- NSTEMI
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)Drug
Also called "Brilinta"
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) Receives: Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Fatal/Life-threatening Bleedings
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Measured: during 1year follow up with ticagrelor treatment
Number of Participants With Bleeding Events (Major Bleedings)
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Measured: during 1year follow up with ticagrelor treatment
Number of Participants With Bleeding Events (Major and Minor Bleedings)
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Measured: during 1year follow up with ticagrelor treatment
Number of Participants With Other Serious Adverse Event (SAEs)
Evaluation of serious adverse events other than bleedings
Measured: during 1year follow up with ticagrelor treatment
Number of Participants With Major Cardiovascular Events
Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke
Measured: during 1year follow up with ticagrelor treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start23 Apr 2015
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non ST-elevation Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chun-peng Liu, Ph.D, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406248
- Sponsor's protocol ID
- D5130C00103
- Status last verified
- Oct 2018
- First submitted
- 19 Mar 2015
- Last updated
- 15 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Cumulative Incidence of Major Cardiovascular Events of Ticagrelor in Taiwanese Patients With Non ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02406248
- Acronym / sponsor ID
- D5130C00103
- Conditions
- Non ST-elevation Myocardial Infarction
- Keywords
- NSTEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Posted 15 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction
Detailed description
This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 20 years
- Patient who is considered as ethnic Taiwanese
- Index event of non-ST elevation myocardial infarction
Key exclusion criteria (5 listed)
- Contraindication or other reason that ticagrelor should not be administered
- Index event is an acute complication of Percutaneous coronary intervention (PCI)
- Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
- Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
- Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)Also: "Brilinta"Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) | Drug | single arm |
Primary outcome
Number of Participants With Fatal/Life-threatening Bleedings
Time frame: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Number of Participants With Bleeding Events (Major Bleedings)
Time frame: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Number of Participants With Bleeding Events (Major and Minor Bleedings)
Time frame: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Number of Participants With Other Serious Adverse Event (SAEs)
Time frame: during 1year follow up with ticagrelor treatment
Evaluation of serious adverse events other than bleedings
Number of Participants With Major Cardiovascular Events
Time frame: during 1year follow up with ticagrelor treatment
Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- RevisedCSP2D5130C00103Redacted\_aLink 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.
Chun-peng Liu, Ph.D principal investigator
Kaohsiung Veterans General Hospital.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) in people with Non ST-elevation Myocardial Infarction, run by AstraZeneca at 13 sites in Taiwan.
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 4 inclusion and 5 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Fatal/Life-threatening Bleedings (time frame: during 1year follow up with ticagrelor treatment). The study lists 5 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 15 Oct 2018.