ACS (Acute Coronary Syndrome) Clinical Trial
Official title:
Non-interventional Prospective Data Collection on Persistence and Adherence on Ticagrelor in ACS Adult Patients in Serbia
| NCT number | NCT03444012 |
| Other study ID # | D5130R00052 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 5, 2018 |
| Est. completion date | August 13, 2019 |
| Verified date | July 2020 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia
| Status | Completed |
| Enrollment | 269 |
| Est. completion date | August 13, 2019 |
| Est. primary completion date | August 13, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Serbia | CHC Bezanijska Kosa | Belgrade | |
| Serbia | CHC Zemun | Belgrade | |
| Serbia | CHC Zvezdara | Belgrade | |
| Serbia | Clinical Center of Serbia | Belgrade | |
| Serbia | Institute for cardiovascular diseases, Dedinje | Belgrade | |
| Serbia | Medical Military Academy | Belgrade | |
| Serbia | Clinical Center Kragujevac | Kragujevac | |
| Serbia | Clinical Center Nis | Nis | |
| Serbia | Institute for cardiovascular diseases of Vojvodina | Sremska Kamenica |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome | 1 year (12 months) |