NCT03315650

Brief Summary

This study evaluates the antithrombotic therapy in patients suffering from atrial fibrillation after stent implantation in Germany. Patients prescribed with the novel oral anticoagulant Rivaroxaban will be followed up over 14 months for their adherence to the medication schedule and for complications that occurred after index PCI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

13 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

First Submitted

Initial submission to the registry

October 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
Last Updated

March 31, 2022

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

October 10, 2017

Last Update Submit

March 30, 2022

Conditions

Non-valvular Atrial FibrillationAcute Coronary SyndromePercutaneous Coronary InterventionAntithrombotic Therapy

Keywords

Non-valvular AFACSPCINOACRivaroxaban

Outcome Measures

Primary Outcomes (1)

  • Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI

    Real-life data on the prescription of antithrombotic medication for patients with atrial fibrillation after PCI

    18 months

Secondary Outcomes (3)

  • Evaluation of antithrombotic medication during long-term follow-up

    14 months

  • Adverse Events during baseline and follow-up

    32 months

  • Treatment adherence of patients

    14 months

Eligibility Criteria

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

Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.

You may qualify if:

  • Age ≥18 years and capable of giving written informed consent
  • Known or newly diagnosed non-valvular atrial fibrillation
  • PCI with stent implantation during index hospital stay
  • Written informed consent for participation in observational study (incl. telephone follow-up)
  • Not simultaneously participating in any randomized trial

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Gesundheitszentrum Bitterfeld-Wolfen

Bitterfeld-Wolfen, 06749, Germany

Location

Klinikum Links der Weser

Bremen, 28277, Germany

Location

Krankenhaus Buchholz

Buchholz, 21244, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

SLK-Kliniken Heilbronn

Heilbronn, 74078, Germany

Location

Städtisches Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Klinikum der Universität München , Campus Großhadern

Munich, 81377, Germany

Location

Kreisklinikum Siegen

Siegen, 57076, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, 78052, Germany

Location

Related Publications (1)

  • Zeymer U, Toelg R, Wienbergen H, Hobbach HP, Cuneo A, Bekeredjian R, Ritter O, Hailer B, Hertting K, Hennersdorf M, Scholtz W, Lanzer P, Mudra H, Schwefer M, Schwimmbeck PL, Liebetrau C, Thiele H, Claas C, Riemer T, Zahn R. Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice. Am J Cardiol. 2023 Feb 15;189:31-37. doi: 10.1016/j.amjcard.2022.11.009. Epub 2022 Dec 6.

    PMID: 36493580DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Uwe Zeymer, Prof. Dr.

    Institut für Herzinfarktforschung (Institute for Cardiac Research)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 20, 2017

Study Start

January 1, 2018

Primary Completion

March 31, 2020

Study Completion

June 24, 2021

Last Updated

March 31, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

An intermediate report summarizing the baseline data will be provided to Bayer (financial support). A final report summarizing baseline and follow-up data will be provided to ethical committees in Germany, to governmental authority, and to Bayer. Participating clinics will receive benchmarking reports (comparison of their own data with those of all other sites). Data will be made accessible to participating investigators for publication in journals and on conferences.

Locations

DE(13)