- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03444012
ADHERE-S (NIS Brilique)
August 5, 2020 updated by: AstraZeneca
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
269
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Belgrade, Serbia
- Clinical Center of Serbia
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Belgrade, Serbia
- CHC Bezanijska Kosa
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Belgrade, Serbia
- Medical Military Academy
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Belgrade, Serbia
- CHC Zemun
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Belgrade, Serbia
- CHC Zvezdara
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Belgrade, Serbia
- Institute for cardiovascular diseases, Dedinje
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Kragujevac, Serbia
- Clinical Center Kragujevac
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Nis, Serbia
- Clinical Center Nis
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Sremska Kamenica, Serbia
- Institute for Cardiovascular Diseases of Vojvodina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult ACS patients
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome
Time Frame: 1 year (12 months)
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1 year (12 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2018
Primary Completion (Actual)
August 13, 2019
Study Completion (Actual)
August 13, 2019
Study Registration Dates
First Submitted
February 9, 2018
First Submitted That Met QC Criteria
February 19, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
August 7, 2020
Last Update Submitted That Met QC Criteria
August 5, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- D5130R00052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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