Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes

Completed

• Conditions: Acute Coronary Syndrome (ACS)

• Registration Number: NCT02265068
• Lead Sponsor: IHF GmbH - Institut für Herzinfarktforschung

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment outcomes of ACS patients receiving Ticagrelor	12 months	Documentation of Events for ACS patients treated with Ticagrelor with follow-up over 12 months

Secondary Outcome Measures

Name	Time	Method
Long-term use and premature discontinuation of Ticagrelor treatment	12 months	Documentation of time span during which Ticagrelor is taken by patient

Trial Locations

Locations (6)

Vivantes-Klinikum Neukölln; 🇩🇪 Berlin, Germany

Klinikum Hildesheim GmbH; 🇩🇪 Hildesheim, Germany

Klinikum-Wetzlar Braunsfeld; 🇩🇪 Wetzlar, Germany

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

Krankenhaus Landshut-Achdorf; 🇩🇪 Landshut, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany