Clinical trial NCT02265068: Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes
Official title: Real-TICA Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes. Evaluation of Antiplatelet Therapy After 12 Months in Patients Undergoing PCI and Treated With Ticagrelor During the Acute Phase of an ACS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome (ACS)
Keywords: Acute coronary syndrome (ACS), Ticagrelor
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients from the ALKK-PCI registry discharged alive after PCI for ACS (STEMI and NSTE-ACS) and treated with ticagrelor during the acute phase.

Brief summary: Documentation of long-term data regarding ticagrelor use and evaluation of reasons for discontinuation of ticagrelor in patients with ACS

Detailed description: REAL-TICA is a retrospective non-interventional study to assess the long-term use of ticagrelor in patients with ACS and to evaluate the reasons for discontinuation of ticagrelor.

For this purpose, selected sites from the ALKK-PCI registry and the respective patients will be identified. The sites' eligibility for this study includes the frequent use of ticagrelor during the acute phase of ACS. Eligible patients are characterised by the diagnosis of ACS and the use of ticagrelor during PCI.

The eligible sites will be contacted by IHF and asked to contact their eligible patients by letter to obtain informed consent of the patients for the planned 12M follow-up by IHF. A detailed questionnaire on events within the last 12 months, current symptoms, current medication and the use of ticagrelor will be added to the patients' letters. Patients then are asked to return their responses on consent to participate in the study as well as the filled in questionnaire to IHF. Alternatively, patients may choose to receive a telephone call by IHF to answer the detailed questionnaire in person. In case of essential information missing, IHF will contact the primary care physician of the patient directly to obtain information about clinical events and medications.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* ACS (STEMI or NSTE-ACS) with PCI
* Ticagrelor treatment during the acute phase
* Written informed consent for participation in the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Treatment outcomes of ACS patients receiving Ticagrelor
timeFrame: 12 months
Secondary outcomes:
measure: Long-term use and premature discontinuation of Ticagrelor treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Vivantes-Klinikum Neukölln
city: Hildesheim
country: Germany
facility: Klinikum Hildesheim GmbH
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Wetzlar
country: Germany
facility: Klinikum-Wetzlar Braunsfeld
Study officials:
affiliation: Klinikum Ludwigshafen, Stiftung IHF - Institut für Herzinfarktforschung
name: Uwe Zeymer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeymer U, Cully M, Hochadel M. Adherence to dual antiplatelet therapy with ticagrelor in patients with acute coronary syndromes treated with percutaneous coronary intervention in real life. Results of the REAL-TICA registry. Eur Heart J Cardiovasc Pharmacother. 2018 Oct 1;4(4):205-210. doi: 10.1093/ehjcvp/pvy018.