Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS)

June 29, 2010 updated by: University of Turku

Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting: A Multicenter, Prospective Registry

Treatment of patients suffering from atrial fibrillation pose problems when percutaneous coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. The management of the antithrombotic treatment before invasive cardiac procedures is also incompletely defined. In this study we aim to determine in patients with atrial fibrillation undergoing PCI-S:

  1. the contemporary antithrombotic management;
  2. the relative safety and efficacy of the various post-PCI antithrombotic regimens;
  3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and bioactive stents (BAS);
  4. the safety of various periprocedural antithrombotic strategies including glycoprotein IIb/IIIa inhibitors and bivalirudin;
  5. safety and efficacy of radial vs femoral approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AFCAS study is an observational, multi-center, prospective registry including patients with atrial fibrillation undergoing PCI-S. Follow-up time is 12 months.

Primary end points are major hemorrhagic and thrombotic/thromboembolic complications including cardiac death and secondary endpoints are Major adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death), stent thrombosis and major/non major hemorrhagic complications. Clinical follow-up will be completed for all patients via telephone, or clinic visits scheduled at 1, 3, 6, and 12 months after PCI-S. The 1 and 6 months visits are optional. The patients will be asked about their clinical outcomes, hospitalizations and medications. Any additional information needed, such as specific mortality, will be obtained by contacting one of the patient's physicians or other health care professional or from death certificates. CRFs will be completed and faxed without delays after discharge, and after each follow up visit. Recruitment will take approximately 12 months. Follow-up will be 12 months for each patient.

Study Type

Observational

Enrollment (Actual)

996

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

  • Finland
      • Turku, Finland, 20520
        • Juhani Airaksinen

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with atrial fibrillation undergoing PCI-S.

Description

Inclusion Criteria:

  • Patients with atrial fibrillation who undergo PCI.

Exclusion Criteria:

  • Because of the observational design, no exclusion criteria are provided.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patient with atrial fibrillation who underwent PCI
Procedure: PCI
Percutaneous coronary interventiom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
major hemorrhagic and thrombotic/thromboembolic complications including cardiac death
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

University of Turku

Investigators

  • Principal Investigator: Juhani KE Airaksinen, Professor, University of Turku

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

January 1, 2007

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2010

Last Update Submitted That Met QC Criteria

June 29, 2010

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12007 (DAIDS-ES Registry Number)

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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