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

Acute Coronary Syndrome (ACS) Clinical Trial

— Real-TICA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265068
• Other study ID #: Real-TICA
• Status: Completed
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Syndrome

Intervention

Drug:
• Ticagrelor
Treatment of ACS patients with Ticagrelor

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Vivantes-Klinikum Neukölln	Berlin
Germany	Klinikum Hildesheim GmbH	Hildesheim
Germany	Krankenhaus Landshut-Achdorf	Landshut
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Klinikum-Wetzlar Braunsfeld	Wetzlar

Sponsors (1)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zeymer U, Cully M, Hochadel M; REAL-TICA Investigators. 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 H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment outcomes of ACS patients receiving Ticagrelor	Documentation of Events for ACS patients treated with Ticagrelor with follow-up over 12 months	12 months
Secondary	Long-term use and premature discontinuation of Ticagrelor treatment	Documentation of time span during which Ticagrelor is taken by patient	12 months