NCT02265068

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 14, 2018

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

October 9, 2014

Last Update Submit

June 13, 2018

Conditions

Keywords

Acute coronary syndrome (ACS), Ticagrelor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Long-term use and premature discontinuation of Ticagrelor treatment

    12 months

Interventions

Treatment of ACS patients with Ticagrelor

Also known as: Anti-platelet therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Vivantes-Klinikum Neukölln

Berlin, 12351, Germany

Location

Klinikum Hildesheim GmbH

Hildesheim, 31135, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, 84036, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

Klinikum-Wetzlar Braunsfeld

Wetzlar, 35578, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

TicagrelorDual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesDrug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Uwe Zeymer, Prof. Dr.

    Klinikum Ludwigshafen, Stiftung IHF - Institut für Herzinfarktforschung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 14, 2018

Record last verified: 2017-02

Locations