NCT00596570

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
996

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 30, 2010

Status Verified

December 1, 2007

First QC Date

January 8, 2008

Last Update Submit

June 29, 2010

Conditions

Keywords

Atrial fibrillationOral AnticoagulationPercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • major hemorrhagic and thrombotic/thromboembolic complications including cardiac death

    one year

Study Arms (1)

1

Patient with atrial fibrillation who underwent PCI

Procedure: PCI

Interventions

PCIPROCEDURE

Percutaneous coronary interventiom

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with atrial fibrillation undergoing PCI-S.

You may qualify if:

  • Patients with atrial fibrillation who undergo PCI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juhani Airaksinen

Turku, 20520, Finland

Location

Related Publications (3)

  • Puurunen M, Kiviniemi T, Nammas W, Schlitt A, Rubboli A, Nyman K, Karjalainen P, Kirchhof P, Lip GY, Airaksinen JK. Impact of anaemia on clinical outcome in patients with atrial fibrillation undergoing percutaneous coronary intervention: insights from the AFCAS registry. BMJ Open. 2014 May 13;4(5):e004700. doi: 10.1136/bmjopen-2013-004700.

  • Rubboli A, Schlitt A, Kiviniemi T, Biancari F, Karjalainen PP, Valencia J, Laine M, Kirchhof P, Niemela M, Vikman S, Lip GY, Airaksinen KE; AFCAS Study Group. One-year outcome of patients with atrial fibrillation undergoing coronary artery stenting: an analysis of the AFCAS registry. Clin Cardiol. 2014 Jun;37(6):357-64. doi: 10.1002/clc.22254. Epub 2014 Jan 30.

  • Schlitt A, Rubboli A, Lip GY, Lahtela H, Valencia J, Karjalainen PP, Weber M, Laine M, Kirchhof P, Niemela M, Vikman S, Buerke M, Airaksinen KE; AFCAS (Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting Study Group). The management of patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation: in-hospital-data from the Atrial Fibrillation undergoing Coronary Artery Stenting study. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):E864-70. doi: 10.1002/ccd.25064. Epub 2013 Aug 28.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anticoagulation samples

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juhani KE Airaksinen, Professor

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

January 1, 2007

Study Completion

February 1, 2010

Last Updated

June 30, 2010

Record last verified: 2007-12

Locations