ACS (Acute Coronary Syndrome)NCT03444012
ADHERE-S (NIS Brilique)
An observational study of ACS (Acute Coronary Syndrome), run by AstraZeneca at 9 sites in Serbia.
Trial summary
noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS (Acute Coronary Syndrome)
- What is being tested?
- ticagrelor 90 mg
- How many people
- 269 participants
- Where
- 9 sitesSerbia
- Study dates
- 5 Mar 2018to 13 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ACS patients
Who may be able to join
- ≥ 18 years of age
- diagnosed with ACS - STEMI or NSTEMI or unstable angina, invasively or non-invasively treated
- Patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. Enrolment in this study must not be trigger for ticagrelor initiation.
- read and signed the Informed Consent Form
Who cannot join
- Any contraindications as per approved SmPC of Brilique
- Patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Serbia9 sites
CHC Bezanijska Kosa
Belgrade
CHC Zemun
Belgrade
CHC Zvezdara
Belgrade
Clinical Center of Serbia
Belgrade
Institute for cardiovascular diseases, Dedinje
Belgrade
Medical Military Academy
Belgrade
Institute for cardiovascular diseases of Vojvodina
Kamenitz
Clinical Center Kragujevac
Kragujevac
Clinical Center Nis
Niš
About this study
Official title: Non-interventional Prospective Data Collection on Persistence and Adherence on Ticagrelor in ACS Adult Patients in Serbia
noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia
- Conditions
- ACS (Acute Coronary Syndrome)
- Being tested
- ticagrelor 90 mg
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelor 90 mgDrug
persistence and adherence on ticagrelor in ACS patients
What is being measured
The primary outcome is the main question the study is designed to answer.
duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome
Measured: 1 year (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start5 Mar 2018
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS (Acute Coronary Syndrome)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444012
- Sponsor's protocol ID
- D5130R00052
- Status last verified
- Jul 2020
- First submitted
- 9 Feb 2018
- Last updated
- 7 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Prospective Data Collection on Persistence and Adherence on Ticagrelor in ACS Adult Patients in Serbia
- ClinicalTrials.gov ID
- NCT03444012
- Acronym / sponsor ID
- D5130R00052
- Conditions
- ACS (Acute Coronary Syndrome)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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.
noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ACS patients
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- diagnosed with ACS - STEMI or NSTEMI or unstable angina, invasively or non-invasively treated
- Patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. Enrolment in this study must not be trigger for ticagrelor initiation.
- read and signed the Informed Consent Form
Key exclusion criteria (2 listed)
- Any contraindications as per approved SmPC of Brilique
- Patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.
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 90 mgpersistence and adherence on ticagrelor in ACS patients | Drug | – |
Primary outcome
duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome
Time frame: 1 year (12 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 7 Aug 2020.
- redacted 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS (Acute Coronary Syndrome), run by AstraZeneca at 9 sites in Serbia.
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 2 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 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Serbia. 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?
duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome (time frame: 1 year (12 months)). 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 7 Aug 2020.