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

June 13, 2018 updated by: IHF GmbH - Institut für Herzinfarktforschung

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

700

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

  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Berlin, Germany, 12351
        • Vivantes-Klinikum Neukölln
      • Hildesheim, Germany, 31135
        • Klinikum Hildesheim GmbH
      • Landshut, Germany, 84036
        • Krankenhaus Landshut-Achdorf
      • Ludwigshafen, Germany
        • Klinikum Ludwigshafen
      • Wetzlar, Germany, 35578
        • Klinikum-Wetzlar Braunsfeld

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

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.

Description

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 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
Measure Description
Time Frame
Treatment outcomes of ACS patients receiving Ticagrelor
Time Frame: 12 months
Documentation of Events for ACS patients treated with Ticagrelor with follow-up over 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term use and premature discontinuation of Ticagrelor treatment
Time Frame: 12 months
Documentation of time span during which Ticagrelor is taken by patient
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Investigators

  • Principal Investigator: Uwe Zeymer, Prof. Dr., Klinikum Ludwigshafen, Stiftung IHF - Institut für Herzinfarktforschung

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.

General Publications

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

August 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Real-TICA

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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